Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

• Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma.

• Assess the toxicity of this treatment in these patients.

• Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, and then every 3 months until disease progression or death.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Susan Burdette-Radoux

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00005971
Information obtained from ClinicalTrials.gov on December 14, 2011

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