Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)
bryostatin 1
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months WBC at least 3,000/mm3 Platelet count at least 100,00/mm3 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min 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: No more than 1 prior therapy with biologic response modifiers No prior chemotherapy for advanced disease No other concurrent chemotherapy No concurrent steriods (except topical use) At least 4 weeks since prior radiotherapy No concurrent radiotherapy At least 4 weeks since major surgery (including nephrectomy) No other concurrent experimental agents
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
Hunterdon Regional Cancer Center
Flemington, United StatesOpen Hunterdon Regional Cancer Center in Google MapsKimball Medical Center
Lakewood, United StatesSouth Jersey Hospital - Millville
Millville, United StatesFox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, United States