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| Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003968 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: bryostatin 1 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999) |
| Study Start Date: | June 1999 |
OBJECTIVES: I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma. II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen. IV. Determine the overall survival of this patient population treated with this regimen.
OUTLINE: Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Bidimensionally measurable disease Clear evidence of progression if only site of measurable disease is within previous radiation port Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,00/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study No active bacterial or viral infection No serious underlying medical condition that would interfere with compliance No other malignancy within the past 5 years except basal cell carcinoma of the skin No dementia or altered mental status that would prevent informed consent
PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior therapy with biologic response modifiers Chemotherapy: No prior chemotherapy for advanced disease No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent steriods (except topical use) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: At least 4 weeks since major surgery (including nephrectomy) Other: No other concurrent experimental agents
Contacts and Locations| United States, New Jersey | |
| Community Medical Center | |
| Toms River, New Jersey, United States, 08755 | |
| Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County | |
| Mount Holly, New Jersey, United States, 08060 | |
| Hunterdon Regional Cancer Center | |
| Flemington, New Jersey, United States, 08822 | |
| St. Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| Riverview Medical Center | |
| Red Bank, New Jersey, United States, 07701 | |
| South Jersey Hospital - Millville | |
| Millville, New Jersey, United States, 08332 | |
| Kimball Medical Center | |
| Lakewood, New Jersey, United States, 08701 | |
| United States, Pennsylvania | |
| Bon Secours-Holy Family Health System | |
| Altoona, Pennsylvania, United States, 16602 | |
| Saint Mary Medical Center | |
| Langhorne, Pennsylvania, United States, 19047 | |
| Delaware County Memorial Hospital | |
| Drexel Hill, Pennsylvania, United States, 19026 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| North Penn Hospital | |
| Lansdale, Pennsylvania, United States, 19446 | |
| Paoli Memorial Hospital | |
| Paoli, Pennsylvania, United States, 19301-1792 | |
| Pinnacle Health Hospitals | |
| Harrisburg, Pennsylvania, United States, 17105-8700 | |
| Pottstown Memorial Regional Cancer Center | |
| Pottstown, Pennsylvania, United States, 19464 | |
| Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19612-6052 | |
| Conemaugh Memorial Hospital | |
| Johnstown, Pennsylvania, United States, 15905 | |
| Study Chair: | Naomi S. Balzer-Haas, MD | Fox Chase Cancer Center |
More Information
| Study ID Numbers: | CDR0000067169, FCCC-99012, NCI-T99-0002 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003968 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV renal cell cancer recurrent renal cell cancer |
|
Urinary Tract Neoplasm Kidney Cancer Immunologic Factors Adjuvants, Immunologic Urogenital Neoplasms Bryostatin 1 Urologic Neoplasms Recurrence |
Carcinoma Renal Cancer Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
|
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic Urogenital Neoplasms Bryostatin 1 Urologic Neoplasms Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |