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Home > "B" Clinical Trials Conditions > Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer  Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NaomiHaas, Study Chair, Fox Chase Cancer Center
Saint Mary Medical Center
Langhorne, Pennsylvania, 19047
United States
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
United States
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
United States
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
South Jersey Hospital - Millville
Millville, New Jersey, 08332
United States
North Penn Hospital
Lansdale, Pennsylvania, 19446
United States
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
Community Medical Center
Toms River, New Jersey, 08755
United States
Kimball Medical Center
Lakewood, New Jersey, 08701
United States
Riverview Medical Center
Red Bank, New Jersey, 07701
United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
United States
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
United States
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
United States
Additional Information:
Study ID Numbers: CDR0000067169; FCCC-99012,NCI-T99-0002
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003968
Other Stage 4 Renal Cell Cancer Studies:
1. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
2. Fluorouracil and Low-Dose Suramin as Chemosensitization in Treating Patients With Metastatic Renal Cell (Kidney) Cancer
3. Interleukin-2, Interferon alfa, and Fluorouracil Compared With Observation in Treating Patients Who Have Undergone Surgery for Kidney Cancer
4. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
5. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer
Related Studies:
Other stage 4 renal cell cancer Clinical Trials
Other New Jersey Clinical Trials
Other Toms River Clinical Trials
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
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