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Clinical Trials


Clinical Trials - Lung Cancer Program at UCLA - Los Angeles, California

Clinical Trials - Lung Cancer Program at UCLA - Los Angeles, California
Clinical Trials - Lung Cancer Program at UCLA - Los Angeles, California

 

A Study of MK-3475 in Patients with Progressive Locally Advanced or Metastatic Carcinomas and Melanoma
IRB#: 11-003066
Principal Investigator: Antoni Ribas P: 310-206-3928
Coordinator: Lauren Hahn

Lay Title:

Study of MK-3475 in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001 AM6)

Description:

This study is for subjects with either metastatic melanoma or non-small cell lung cancer. The purpose of this study is to test how much of the investigational drug MK-3475 can be given safely to subjects without causing any harmful side effects. MK-3475 is an anti-PD-1 antibody given by intravenous infusion every three weeks. Being an investigational drug, MK-3475 has not yet been approved by the United States Food and Drug Administration (US FDA). The research doctors want to find out what effect, good or bad MK-3475 has on patients with either metastatic melanoma or non-small cell lung cancer. All eligible subjects enrolled on the study will receive MK-3475, the dosage of which will depend on whether or not they received a drug called ipilimumab as previous treatment for melanoma.

Eligibility:

This study is for subjects, male or female ≥18 years of age with either metastatic melanoma or non-small cell lung cancer.

Technical Description:

This study will be done in 6 parts. In Part A the dose of intravenous (IV) MK-3475 will be escalated to find the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically or cytologically confirmed diagnosis of any type of carcinoma or melanoma (MEL). Part B of the study will explore the safety, tolerability, and efficacy of the drug in participants with advanced or metastatic MEL. Part C of the study will explore the safety, tolerability, and efficacy of the drug in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will explore the low and high doses of study drug identified in Parts A and B in participants with advanced or metastatic MEL. Part E will explore low, medium, and high doses of study drug in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will explore low and high doses of study drug in participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. In Parts D, E, and F participants will be randomized to one dose level.

Technical Eligibility:

Inclusion criteria

  • In Part A: Histological or cytological diagnosis of MEL or any type of carcinoma, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy. In Parts B and D of the study, histological or cytological diagnoses of metastatic MEL with progressive locally advanced or metastatic disease. In Parts C, E and F, histological or cytological diagnosis of NSCLC.
  • Failure of established standard medical anti-cancer therapies for a given tumor type or intolerance to such therapy.
  • In Parts B, C, D, E, or F of the study, MEL or NSCLC must be measurable by imaging.
  • In Parts E and F of the study, NSCLC with PD-L1 gene expression.
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  • Adequate organ function.

Exclusion criteria

  • Chemotherapy, radioactive, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the adverse events caused by therapy administered more than 4 weeks prior to first dose.
  • Participation in a study of an investigational agent or using an investigational device within 30 days of administration of MK-3475.
  • Other form(s) of antineoplastic therapy anticipated during the period of the study.
  • Chronic systemic steroid therapy, or on any other form of immunosuppressive medication.
  • History of acute diverticulitis, intra-abdominal abscess, GI obstruction, abdominal carcinomatosis.
  • History of a hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless no evidence of that disease for 5 years.
  • Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Previous severe hypersensitivity reaction to another monoclonal antibody (mAb).
  • Active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents, except vitiligo or resolved childhood asthma/atopy.
  • Prior therapy with another anti-programmed cell death (PD)-1 agent or an antibody targeting other immuno-regulatory receptors or mechanisms.
  • Active infection requiring therapy.
  • Positive for Human Immunodeficiency Virus (HIV), Hepatitis B (Hepatitis B Surface Antigen [HBsAg] reactive), or Hepatitis C virus (Hepatitis C Virus Ribonucleic Acid [HCV RNA] (qualitative) is detected).
  • Regular use of illicit drugs or a recent history (within the last year) of substance abuse (including alcohol).
  • Symptomatic ascites or pleural effusion.
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.

 

A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination with Docetaxel Versus Docetaxel alone in subjects with stage IIIB or IV non-Small-Cell Lung Cancer.
IRB#: 12-000035
Principal Investigator: Jonathan Goldman P: 888-798-0719
Coordinator: Suzanne Nicholas

Lay Title:

Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

Description:

This study is for subjects with stage IIIB or IV non-small cell lung cancer who have failed one prior systemic therapy for advanced disease. The purpose of this study is to test the combination of ganetespib and docetaxel and compare it with docetaxel alone in patients with the above condition. Giving these treatments together may make the cancer shrink or slow down its growth more than it would if they got treated with docetaxel alone. Docetaxel is FDA approved for the treatment of locally advanced or metastatic non-small cell lung cancer. Ganetespib is an experimental drug; not approved by the Food and Drug Administration (FDA). Eligible subjects who decide to enroll will be randomly assigned to one of two treatment arms. Those in arm A will receive docetaxel alone, while those in arm B will receive docetaxel in combination with ganetespib (study drug).

Eligibility:

This study is for subjects, male or female ≥18 years of age with stage IIIB or IV non-small cell lung cancer.

Technical Description:

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Technical Eligibility:

Inclusion Criteria:

  • confirmed diagnosis of NSCLC
  • Stage IIIB or IV NSCLC
  • ECOG Performance Status 0 or 1
  • Prior therapy defined as 1 prior systemic therapy for advanced disease
  • measurable disease
  • Radiologic evidence of disease progression following most recent prior treatment.
  • Adequate hematologic, hepatic, renal function

Exclusion Criteria:

  • Active or untreated CNS metastases
  • Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  • Serious cardiac illness or medical conditions
  • Pregnant or lactating women
  • Uncontrolled intercurrent illness

 

A Randomized, Phase II, Multicenter, Double Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Metmab In Combination With Either Bevacizumab + Platinum + Paclitaxel Or Pemetrexed + Platinum As First-Line Treatment In Patients With Stage IIIB Or IV Non Squamous Small Cell Lung Cancer (NSCLC)-Non
IRB#: 12-000470
Principal Investigator: Fairooz Kabbinavar P: 310-206-3921
Coordinator: Sandra Hernandez

Lay Title:

A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

Description:

This study is for subjects with stage IIIb or IV non-squamous non-small cell lung cancer (NSCLC).They must have received no more than one previous chemotherapy for this condition at least 12 months ago. The purpose of this study is to determine the safety and efficacy of MetMab in the treatment of patients with non-squamous NSCLC. MetMab is an investigational agent, which means it has not yet been approved by the United States Food and Drug Administration (US FDA) for the treatment of this type of cancer. All eligible subjects enrolled on the study will receive one of two standard of care treatments for non-squamous NSCLC, which are paclitaxel + bevacizumab with either cisplatin or carboplatin or premetrexed with either cisplatin or carboplatin. Half of the subjects will also receive metmab, while the other half will receive an inactive substitute (placebo). This is a double-blind study which means neither the subject nor the doctor know who is assigned to which treatment group.

Eligibility:

This study is for subjects, male or female ≥18 years of age with stage IIIB or IV non squamous non-small cell lung cancer.

Technical Description:

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Technical Eligibility:

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • For patients who received prior adjuvant chemotherapy: a treatment-free interval of at least 12 months since last chemotherapy cycle
  • Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
  • Radiographic evidence of disease

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB or IV non-squamous NSCLC
  • Evidence of mixed NSCLC with a predominance of the squamous cell type
  • Prior exposure to experimental treatment targeting either the HGF or Met pathway
  • Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
  • Known central nervous system (CNS) disease, other than stable, treated brain metastases
  • History of another malignancy in the previous 3 years, except for history of in situ cancer or basal or squamous cell skin cancer
  • Uncontrolled diabetes
  • Pregnant or lactating women
  • Impaired bone marrow, liver or renal function (as defined by protocol)
  • Significant history of cardiovascular disease
  • Positive for HIV infection

 

A Randomized, Phase II, Multicenter, Double-Blind, Placebo Controlled Study Evaluating The Efficacy And Safety Of MetMAb In Combination With Paclitaxel + Cisplatin Or Carboplatin As First-Line Treatment For Patients With Stage IIIb (T4 Disease) Or Iv Squamous Non¿Small Cell Lung Cancer (NSCLC)
IRB#: 12-000408
Principal Investigator: Fairooz Kabbinavar P: 310-206-3921
Coordinator: Sandra Hernandez

Lay Title:

A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

Description:

This study is for subjects with stage IIIb or IV squamous non-small cell lung cancer (NSCLC), who have not received any prior systemic chemotherapy for this condition. The purpose of this study is to determine the safety and efficacy of MetMab in the treatment of patients with squamous NSCLC. MetMab is an investigational agent, which means it has not yet been approved by the United States Food and Drug Administration (US FDA) for the treatment of this type of cancer. All eligible subjects enrolled on the study will receive the standard of care treatment for squamous NSCLC, which is paclitaxel with either cisplatin or carboplatin. Half of the subjects will also receive MetMAb, while the other half will receive an inactive substitute (placebo). This is a double-blind study which means neither the subject nor the doctor know who is assigned to which treatment group.

Eligibility:

This study is for subjects, male or female ≥18 years of age with stage IIIb (T4 Disease) Or IV squamous non-small cell lung cancer (NSCLC).

Technical Description:

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Technical Eligibility:

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No prior chemotherapy for squamous NSCLC
  • Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
  • Radiographic evidence of disease

Exclusion Criteria:

  • Prior systemic treatment for Stage IIIB or IV squamous NSCLC
  • NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
  • Prior exposure to experimental treatment targeting either the HGF or Met pathway
  • Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
  • Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
  • History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
  • Pregnant or lactating women
  • Uncontrolled diabetes
  • Impaired bone marrow, liver or renal function as defined by protocol
  • Significant history of cardiovascular disease
  • Positive for HIV infection

 

Phase I dose escalation study of carboplatin, pemetrexed and exemestane in post-menopausal women with metastatic non-squamous, non-small cell lung cancer
IRB#: 11-003323
Principal Investigator: Edward Garon P: 310-586-2098
Coordinator: Lisa Yonemoto

Lay Title:

Exemestane, Pemetrexed Disodium, and Carboplatin in Treating Post-Menopausal Women With Stage IV Non-Small Cell Lung Cancer

Description:

This study is for post-menopausal women with metastatic non-squamous non-small cell lung cancer that has not been previously treated or has been treated with only an oral therapy. The study involves administration of a combination of drugs, exemestane, pemetrexed and carboplatin. Pemetrexed and carboplatin have been approved by the Food and Drug Administration (FDA) for treatment of patients who have not previously received chemotherapy. Both are traditional chemotherapy drugs, used to treat patients with metastatic lung cancer. Exemestane has been approved by the FDA for the treatment of postmenopausal women with advanced breast cancer. It has not been approved by the FDA for treatment of non-small cell lung cancer. The purpose of this study is to find out how much of exemestane can be safely added to standard chemotherapy with pemetrexed and carboplatin in patients with metastatic non-small cell lung cancer without causing harmful side effects.  Eligible subjects who decide to enroll in the study will receive the 3 drugs. The dosage of exemestane will be determined based on the experience of the patients previously enrolled in the study.

Eligibility:

This study is for post-menopausal women with metastatic non-squamous non-small cell lung cancer that has not been previously treated or has been treated with only an oral therapy.

Technical Description:

This phase I trial studies the side effects and best dose of exemestane in combination with pemetrexed disodium and carboplatin in treating post-menopausal women with stage IV non-small cell lung cancer. Exemestane may stop the growth of tumor calls by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving exemestane together with pemetrexed disodium and carboplatin may kill more tumor cells

Technical Eligibility:

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI)
  • Histologically or cytologically confirmed, treatment-naive (or status post a single treatment regimen of a tyrosine kinase inhibitor as a single agent) stage IV non-squamous, NSCLC
  • Measurable disease according to modified RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Expected survival time of >= 3 months in the opinion of the investigator
  • Postmenopausal women; women are eligible if they are postmenopausal (older than 50 years of age with no spontaneous menses for at least 12 months; or 50 years of age or younger either with no spontaneous menses [amenorrheic] within 12 months of randomization [e.g., spontaneous or secondary to hysterectomy] and a follicle-stimulating hormone level within the postmenopausal range or with prior bilateral oophorectomy)
  • Ability to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample containing representative tumor tissue from a previously obtained biopsy/resection that meets specific tissue sample requirements at screening

Exclusion Criteria:

  • History of another primary cancer within 3 years prior to day 1 with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ
  • Untreated central nervous system (CNS) involvement; (treated CNS involvement is permitted only if the patient is not currently on steroid therapy or has remained on a stable, unchanged dose of steroid for >= 3 weeks)
  • Recent major surgery within the prior 4 weeks; (mediastinoscopy or placement of a central venous access will be allowed as long as placement was more than 7 days prior to receiving study drug)
  • Any prior or concurrent investigational or standard therapy for treatment of metastatic NSCLC including radiation therapy, chemotherapy, biological therapy (with the exception of a single treatment regimen of a tyrosine kinase inhibitor as a single agent, which must be completed 28 days prior to day 1), hormonal therapy, or immunotherapy; (palliative-targeted radiotherapy for brain or bone metastases is permitted providing it has been at least 14 days prior to day 1)
  • History of hormone replacement therapy (estrogens with or without progestin) or an aromatase inhibitor (anastrazole, letrozole, exemestane) within 8 weeks prior to day 1
  • Osteoporosis complicated by pathologic fracture
  • Concurrent investigational agents for non-malignant disease or prior investigational agents for non-malignant disease within 4 weeks or 5 half-lives (whichever is shorter) prior to day 1
  • Concurrent cytotoxic or immunosuppressive therapy for non-malignant disease (e.g., for rheumatoid arthritis or lupus)
  • Absolute neutrophil count (ANC) < 1500/mL
  • Platelet count < 100,000/mL
  • Hemoglobin < 9.0 g/dL
  • Serum bilirubin > 1.5 x upper limits of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x ULN (AST and ALT > 5 x ULN for subjects with liver metastasis)
  • Glomerular filtration rate (GFR) =< 50
  • Albumin =< 2.5 g/dL
  • Known history of or positive test result for human immunodeficiency virus (HIV)
  • Active infection (including HIV/acquired immune deficiency syndrome [AIDS], hepatitis B, or hepatitis C infection) requiring systemic antibiotics, antivirals, or antifungals
  • History of myocardial infarction within 12 months prior to day 1 or clinically significant coronary disease
  • New York Heart Association grade II or greater congestive heart failure
  • Unstable coronary disease or clinically significant electrocardiogram (ECG) (12-lead) abnormalities, as determined by the investigator
  • Inability to comply with study and follow-up procedures
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications
  • Other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrollment

 

A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
IRB#: 12-000055
Principal Investigator: Jonathan Goldman P: 888-798-0719
Coordinator: Suzanne Nichols

Lay Title:

Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of CO-1686 in Previously Treated Mutant Epidermal Growth Factor Receptor (EGFR) Non-Small Cell Lung Cancer (NSCLC)

Description:

This study is for subjects with non-small cell lung cancer that has not responded to treatment. The purpose of this study is to see how much of the oral drug CO-1686 can be given safely to patients with lung cancer without causing harmful side effects. CO-1686 is an investigational drug, which means it is not yet approved by the US Food and Drug Administration (FDA) for treatment of any disease condition, except in a research setting. Patients must have an aberrant form of the epidermal growth factor receptor protein (EGFR) that will be targeted by CO-1686. This may promote cell death in tumor cells that have the abnormal form of the protein. All eligible subjects who decide to enroll will be assigned to receive a certain dose level of the drug, depending on the stage at which they enter the study. The study doctors will then assess the effects, good and bad of the study drug on the subjects and their disease condition.

Eligibility:

This study is for subjects, male and female ≥18 years of age with previously treated mutant EGFR non-small cell lung cancer.

Technical Description:

The purpose of this study is to characterize safety, PK and preliminary efficacy of CO-1686 in patients with mutant EGFR Non-Small Cell Lung Cancer.

Technical Eligibility:

Inclusion Criteria:
Phase 1 or 2
1. Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent NSCLC
2. Documented evidence of any activating mutation in the EGFR determined by either sequencing or PCR-based testing of the tumor tissue using local laboratory technique
3. Have undergone biopsy of either primary or metastatic tumor tissue within 28 days of dosing study drug and have tissue available to send to sponsor lab or are able to undergo a biopsy during screening
4. Life expectancy of at least 3 months
5. ECOG performance status of 0 to 1
6. Age ≥ 18 years
7. Adequate hematological and biological function
8. Written consent on an Institutional Review Board/Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation
Patients enrolling into Phase 1 must also meet the following criteria:
1. Prior treatment with EGFR-directed therapy (eg. erlotinib, gefitinib, neratinib, afatinib, or dacomitinib [PF299804]) Prior chemotherapy, including intervening chemotherapy, is allowed.

  • The washout period for a reversible EGFR inhibitor (erlotinib, gefitinib) is a minimum of 5 days.
  • The washout period for an irreversible EGFR inhibitor (neratinib, afatinib, dacomitinib) is a minimum of 14 days.
  • The washout period for chemotherapy is a minimum of 14 days.
  • Any toxicity related to prior treatment must have resolved to Grade 1 or less.

2. Be willing and able to eat a high-fat breakfast on Day 1 of the study (only applicable to food-effect cohort).
Patients enrolling into Phase 2 must also meet the following criteria:
1. Disease progression while on treatment with EGFR-directed therapy (e.g. erlotinib, gefitinib, neratinib, afatinib, or dacomitinib [PF299804]) with no intervening treatment allowed after most recent EGFR-directed therapy. Prior chemotherapy is allowed as long as the most recent treatment was an EGFR-directed therapy.

  • The washout period for a reversible EGFR inhibitor (erlotinib, gefitinib) is a minimum of 5 days.
  • The washout period for an irreversible EGFR inhibitor (neratinib, afatinib, dacomitinib) is a minimum of 14 days.
  • Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less.

2. Documented evidence of T790M mutation in EGFR as determined by PCR-based testing of tumor tissue using sponsor central lab following disease progression on most recent prior EGFR-directed therapy.
3. Measurable disease according to RECIST Version 1.1.
Exclusion Criteria:
1. History of prior malignancy except:

  • Curatively treated non-melanoma skin cancer
  • Curatively treated in-situ cervical cancer
  • Incidental histologic finding of prostate cancer (tumor/node/metastasis [TNM] stage of T1a or T1b)

2. History of interstitial lung disease related to prior EGFR inhibitor therapy
3. Symptomatic brain metastases
4. Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation [except palliative radiation therapy on non-target lesions for patients without progression], hormonal treatment [except corticosteroids and megestrol acetate], or immunotherapy) ≤14 days prior to treatment with CO-1686
5. Prior treatment with CO-1686
6. Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) >450 msec (males) or >470 msec (females), PR >240 msec, or QRS >110 msec
7. Family history of long QT syndrome
8. Implantable pacemaker or implantable cardioverter defibrillator
9. For phase 1 patients, treatment with any medication known to produce QT prolongation
10. Non-study related surgical procedures ≤14 days prior to administration of CO-1686. In all cases, the patient must be sufficiently recovered and stable before treatment administration.
11. Females who are pregnant or breastfeeding
12. Refusal to use adequate contraception for fertile patients (females and males) for 6 months after the last dose of CO-1686
13. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism)
14. Any other reason the investigator considers the patient should not participate in the study

 

A PHASE 1/2 STUDY TO ASSESS THE SAFETY, AND EFFICACY OF LORVOTUZUMAB MERTANSINE(IMGN901) IN COMBINATION WITH CARBOPLATIN/ETOPOSIDE IN PATIENTS WITH ADVANCED SOLID TUMORS INCLUDING EXTENSIVE STAGE SMALL CELL LUNG CANCER
IRB#: 11-003424
Principal Investigator: Jonathan Goldman P: 888-798-0719
Coordinator: Shaneice Payne

Lay Title:

A Study to Test Safety and Efficacy of IMGN901 in Combination With Carboplatin/Etoposide in Patients With Advanced Solid Tumors and Extensive Stage Small Cell Lung Cancer

Description:

This study is for subjects with small cell lung cancer. The purpose of this study is to compare the effects, good and/or bad, of giving IMGN901 with carboplatin/etoposide chemotherapy followed by IMGN901 alone to giving only carboplatin/etoposide chemotherapy. IMGN901 is an investigational drug, which means it has not been approved by the US Food and Drug Administration for treatment of any condition. This study has 2 parts, phase 1 and phase 2. Phase 1 part of the study is already completed and subjects are now being enrolled for phase 2. Eligible subjects who decide to enroll will be randomly assigned to one of two treatments groups. Subjects in group 1 will receive carboplatin/etoposide + IMGN901 and those in group 2 you will receive carboplatin/etoposide only.

Eligibility:

This study is for subjects, male or female ≥18 years of age with small cell lung cancer.

Technical Description:

The purpose of this study is to test safety and efficacy of this combination treatment (IMGN901, carboplatin and etoposide) in patients with solid tumors and extensive stage small cell lung cancer.

Technical Eligibility:

Inclusion Criteria:

  • Patients must be 18 years old
  • Patients must have been diagnosed with small-cell lung cancer (SCLC) and extensive disease
  • ECOG performance status of 0, 1, or 2
  • No prior systemic chemotherapy for the treatment of SCLC

Exclusion Criteria:

  • Pregnant or lactating females

 

A Phase I Trial of Intratumoral Administration of CCL21 Gene-Modified Autologous Dendritic Cells in Advanced Non-Small Cell Lung Cancer.
IRB#: 03-06-008,10-000039
Principal Investigator: Jay Lee P: 310-794-7333
Coordinator: Fran Rosen

Lay Title:

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Description:

This study is for patients with non-small cell lung cancer that has been resistant (refractory) to standard cancer treatment.  These patients have cells taken from their blood samples (autologous dendritic cells)  and those cells are modified genetically to turn them into cells that will attack the cancer cells. These cell changes are made at the microscopic level. The modified cells are then injected directly into the patient’s lung cancer tumor.  Each patient receives only their own modified cells (autologous).  This study is designed to find out what the maximum safe dosage (MTD or maximum tolerated dose) of this treatment is.  Three patients will receive the first dose and if they show no signs of unwanted side effects, three more patients are given a slightly higher dosage. This continues until patients begin to show signs of unwanted side effects.  At that point the next highest dose becomes the MTD.

Eligibility:

  • Confirmed diagnosis of non-small cell lung cancer that is measurable.
  • Stages III or IV disease.
  • Tumor is accessible by CT-guided intervention or bronchoscopy.
  • Refractory to standard treatment.
  • For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Technical Description:

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Technical Eligibility:

Inclusion Criteria:

  • Adults over the age of 21 capable of giving informed consent
  • Pathologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IIIB, IV, or recurrent disease
  • Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refuses standard chemotherapy
  • Measurable metastatic disease by RECIST guidelines
  • Patients with a major endobronchial lesion in the segmental, lobar, or mainstem bronchus with complete obstruction of the airway may be eligible for bronchoscopic injection provided there is no evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
  • Patients with an endobronchial lesion in the segmental bronchus with variable stenosis (not completely obstructed) and not amenable to standard palliative airway treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if there is no evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 liters)
  • Patients with bullous disease may undergo CT-guided transthoracic injection provided the targeted tumor has an intended needle path without crossing bullae
  • ECOG performance status 0-2
  • BUN ≤ 40 OR serum creatinine ≤ 2
  • Serum total bilirubin ≤ 1.5 OR serum transaminases ≤ 2.5 times upper limit of normal (ULN)
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 14 days since prior acute therapy for viral, bacterial, or fungal infections
  • More than 30 days since prior and no concurrent corticosteroids
  • More than 30 days since prior radiotherapy, chemotherapy, or noncytotoxic investigational agents

Exclusion Criteria:

  • active CNS metastasis (i.e., progression of CNS disease during the past 30 days without intervention)
  • evidence of coagulopathy, defined as PT and/or PTT ≤ 1.5 times ULN OR platelets ≥ 100,000/mm^3
  • evidence of leukoplakia, defined as absolute neutrophil count ≥ 1,500/mm^3
  • evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
  • NYHA class III-IV cardiac disease within the past year
  • myocardial infarction within the past year
  • comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
  • acute viral, bacterial, or fungal infection that requires specific therapy
  • HIV positivity
  • hypersensitivity to any reagents used in the study
  • signs or symptoms of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
  • prior or concurrent evidence of autoimmune disease
  • pregnant or nursing
  • prior organ allograft