Official Title: “A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma”

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.

Study Type: Interventional

Study Design: Treatment

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.

Intervention(s) in this Clinical Trial

• Drug: alvocidib

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute of Canada

Overall Clinical Trial Officials and Contacts

Susan Burdette-Radoux, MD Study Chair McGill Cancer Centre at McGill University  

Information obtained from ClinicalTrials.gov on August 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00005971

Study ID Number: CDR0000067955

ClinicalTrials.gov Identifier: NCT00005971

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database