Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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 I trial to study the effectiveness of cisplatin plus bryostatin 1 in treating patients who have advanced cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lombardi Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Cisplatin

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, incurable solid tumor that is unresectable or has distant metastasis for which a more effective therapy does not exist No active CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Transaminases no greater than 2.5 times normal PT and PTT no greater than 1.25 times upper limit of normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within past 6 months No congestive heart failure or serious arrhythmias requiring treatment Other: No greater than grade 2 neuropathy (including hearing loss) No frequent vomiting or severe anorexia No recent loss of greater than 10% of body weight Not pregnant or nursing Fertile patients must use effective birth control during and for at least 6 months after study No serious concurrent medical illness that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered from toxic effects No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (at least 6 weeks since prior mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy allowed if patient has progressive disease while receiving hormonal therapy for at least three months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiation therapy Surgery: At least 21 days since prior major surgery Other: Any drugs that affect hepatic or renal function must be given as a stable dose and should not be initiated after patient enters study