Clinical trial · Interventional
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
NCT00005971CI-TRIAL-00044588completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic malignant melanoma not amenable to standard curative therapies * No prior regional or systemic therapy for metastatic disease * Measurable disease * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Bone lesions not considered measurable * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 2.5 times ULN Renal: * Creatinine no greater than ULN Cardiovascular: * If history of cardiac disease, ejection fraction greater than 50% * No clinically significant cardiac symptomology Pulmonary: * If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted * No clinically significant pulmonary symptomology Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent serious disease PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior adjuvant immunotherapy allowed * No prior immunotherapy for metastatic disease Chemotherapy: * No prior chemotherapy for metastatic disease * No other concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior adjuvant hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * Must have measurable disease outside irradiated area OR * Evidence of progression or new lesions in irradiated area * No more than 25% of functioning bone marrow irradiated * No concurrent radiotherapy to sole site of measurable disease Surgery: * At least 4 weeks since prior major surgery Other: * No other concurrent anticancer therapy or investigational anticancer agents
References
Publications (2)
- RESULTBurdette-Radoux S, Tozer RG, Lohmann RC, Quirt I, Ernst DS, Walsh W, Wainman N, Colevas AD, Eisenhauer EA. Phase II trial of flavopiridol, a cyclin dependent kinase inhibitor, in untreated metastatic malignant melanoma. Invest New Drugs. 2004 Aug;22(3):315-22. doi: 10.1023/B:DRUG.0000026258.02846.1c. PMID 15122079
- RESULTBurdette-Radoux S, Tozer RG, Lohmann R, et al.: NCIC CTG phase II study of flavopiridol in patients with previously untreated metastatic malignant melanoma (IND.137). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1382, 2002.