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Home > "C" Clinical Trials Conditions > Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer  Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Lombardi Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of combination bryostatin 1 and cisplatin chemotherapy in patients with advanced, incurable solid tumors. PROTOCOL OUTLINE: This is a dose escalation study. The first 4 cohorts of patients receive an escalating dose of cisplatin with a fixed dose of bryostatin 1, followed by 5 cohorts receiving an escalating dose of bryostatin 1 and a fixed dose of cisplatin. In the first course, cisplatin is given as a 2 hour infusion followed by a 24 hour continuous infusion of bryostatin 1. In all subsequent courses bryostatin 1 is given first and cisplatin afterwards. Treatment continues every 21 days in patients with stable or responding disease. Dose escalation proceeds until the maximum tolerated dose (MTD) of the combination chemotherapy is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. After the MTD is determined, an additional 10 patients are treated at this dose level. Patients are followed at 1 month. PROJECTED ACCRUAL: Approximately 24-30 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, incurable solid tumor that is unresectable or has distant metastasis for which a more effective therapy does not exist - No active CNS metastases --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 --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 clinically apparent neuropathy; 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnMarshall, Study Chair, Lombardi Cancer Research Center
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000065849; GUMC-97166,NCI-T97-0056
Study Start Date: October 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003108
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Creatine in Treating Patients With Cancer-Associated Weight Loss
2. Flavopiridol, Oxaliplatin, Fluorouracil, and Leucovorin in Treating Patients With Advanced Solid Tumors
3. Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
4. Paclitaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
5. Evaluating Patient Participation in Phase I Clinical Trials
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Cisplatin Plus Bryostatin 1 in Treating Patients With Advanced Cancer
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