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Flavopiridol in Treating Patients With Refractory Cancer



Flavopiridol in Treating Patients With Refractory Cancer

For Condition: Leukemia,Eye Cancer,Prostate Cancer,Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer.
Details: OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of flavopiridol in patients with solid tumors or lymphoma. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive flavopiridol IV over 1 hour on day 1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of 3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the next level is permitted in the absence of DLT. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 27 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven refractory solid tumor or refractory lymphoma requiring systemic therapy - No standard therapeutic options - Measurable disease - Prostate patients: Tumor progression during blockade of testicular and adrenal androgen required PSA elevation on 2 consecutive blood samples, 2 weeks apart; Serum testosterone concentrations in the castrate range - No CNS neoplasms --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered (6 weeks since prior nitrosoureas or mitomycin); No prior flavopiridol; No concurrent antineoplastic therapy except for GnRH for prostate cancer - Endocrine therapy: At least 4 weeks since prior flutamide or other antiandrogen therapy without disease improvement; At least 4 weeks since prior hormonal therapy for breast carcinoma and must show evidence of disease progression; No concurrent corticosteroids except for physiological replacement - Radiotherapy: At least 4 weeks since prior radiotherapy and recoveredt At least 6 weeks since prior bone seeking radioisotope therapy - Surgery: Not specified - Other: At least 3 months since prior suramin treatment; At least 2 months since prior treatment with UCN-01; No concurrent anticoagulation therapy --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 75,000/mm3; Absolute granulocyte count at least 1,000/mm3; No active coagulopathy requiring therapeutic anticoagulation - Hepatic: SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN); Bilirubin no greater than 1.5 times ULN (no greater than 3 times ULN if Gilbert's disease present) - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No history of unstable or newly diagnosed angina pectoris; No myocardial infarction within past 6 months; No New York Heart Association class II-IV heart disease - Other: No serious concurrent medical illness; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WyndhamWilson,  Study Chair,  National Cancer Institute (NCI)

Medicine Branch
Bethesda,  Maryland,  20892
United States
 


Additional Information:
Study ID Numbers:  CDR0000065779;  NCI-97-C-0171C,NCI-T97-0064
Study Start Date: August 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019344

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