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| ID | Type | Description | Link |
|---|---|---|---|
| UCCRC-10337 | |||
| NCI-T99-0018 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 plus paclitaxel in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
OBJECTIVES: I. Determine the overall, partial, and complete response rates in patients with stage IIIB-IV or recurrent non-small cell lung cancer treated with bryostatin 1 and paclitaxel. II. Determine the overall survival and time to tumor progression in patients treated with this regimen. III. Determine the T cell subset analysis and serum levels of interleukin-6 and tumor necrosis factor alpha in these patients after receiving bryostatin 1 and correlate with clinical endpoints.
OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed for at least 2 years for survival.
PROJECTED ACCRUAL: A total of 15-40 patients will be accrued for this study within 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Paclitaxel (90 mg/m2, days 1, 8 and 15 of every 28 day cycle), Bryostatin-1 (50 mcg/m2, days 2, 9 and 16 of every 28 day cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bryostatin 1 | Drug |
| ||
| paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate | 3 years |
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DISEASE CHARACTERISTICS: Histologically or cytologically proven stage IIIB, IV or recurrent non-small cell lung cancer (NSCLC) Patients with stage IIIB disease must have pleural effusion Measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin normal SGOT less than 2 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Blood urea nitrogen less than 1.5 times normal Cardiovascular: No symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months No heart block worse than first degree, bundle branch block, or ventricular or supraventricular arrhythmia by 12 lead electrocardiogram Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled concurrent illness including, but not limited to, ongoing or active infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: Greater than 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients
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| Name | Affiliation | Role |
|---|---|---|
| Ann M. Mauer, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Chicago Cancer Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12581572 | Result | Winegarden JD, Mauer AM, Gajewski TF, Hoffman PC, Krauss S, Rudin CM, Vokes EE. A phase II study of bryostatin-1 and paclitaxel in patients with advanced non-small cell lung cancer. Lung Cancer. 2003 Feb;39(2):191-6. doi: 10.1016/s0169-5002(02)00447-6. |
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|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| Evanston Northwestern Health Care | Evanston | Illinois | 60201 | United States |
| Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068 | United States |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria | Illinois | 61602 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62701 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46885-5099 | United States |
| Michiana Hematology/Oncology P.C. | South Bend | Indiana | 46617 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| C046785 | bryostatin 1 |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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