Overview
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
Status:
Completed
Completed
Trial end date:
2009-12-21
2009-12-21
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
NCIC Clinical Trials GroupTreatments:
Alvocidib
Criteria
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