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Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
Study NCT00003968   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: October 12, 2008   History of Changes

November 1, 1999
October 12, 2008
June 1999
 
 
 
Complete list of historical versions of study NCT00003968 on ClinicalTrials.gov Archive Site
 
 
 
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

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.

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.

Phase II
Interventional
Treatment
Kidney Cancer
Drug: bryostatin 1
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003968
 
CDR0000067169, FCCC-99012, NCI-T99-0002
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Naomi S. Balzer-Haas, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP