Flavopiridol in Treating Patients With Refractory Cancer
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| ClinicalTrials.gov Identifier: NCT00019344 |
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Recruitment Status :
Completed
First Posted : April 21, 2004
Last Update Posted : April 29, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma Prostate Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific | Drug: alvocidib | Phase 1 |
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the pharmacokinetics of this drug in these patients.
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: Approximately 36 patients will be accrued for this study within 27 months.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms |
| Study Start Date : | August 1997 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven refractory solid tumor or lymphoma requiring systemic therapy No standard therapeutic options exist Prostate cancer 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 Leuprolide or other gonadotropin-releasing hormone (GnRH) analogs maintained if no prior orchiectomy No CNS neoplasms
PATIENT CHARACTERISTICS: Age: 18 and over 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 normal Bilirubin no greater than 1.5 times normal (3 times normal 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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior flavopiridol Endocrine therapy: See Disease Characteristics A 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 recovered 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 UCN-01 No concurrent anticoagulation therapy No other concurrent antineoplastic therapy except for GnRH for prostate cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019344
| United States, Maryland | |
| Medicine Branch | |
| Bethesda, Maryland, United States, 20892 | |
| Study Chair: | Edward A. Sausville, MD, PhD | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019344 |
| Obsolete Identifiers: | NCT00001585 |
| Other Study ID Numbers: |
CDR0000065779 NCI-97-C-0171C NCI-T97-0064 |
| First Posted: | April 21, 2004 Key Record Dates |
| Last Update Posted: | April 29, 2015 |
| Last Verified: | May 2002 |
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stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma stage IV prostate cancer recurrent prostate cancer unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma |
stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma intraocular lymphoma stage IV mantle cell lymphoma |
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Lymphoma Prostatic Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Alvocidib Antineoplastic Agents Growth Inhibitors Growth Substances Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |