Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

NCIC Clinical Trials Group

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: alvocidib

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00005971

CDR0000067955 (Other Identifier)

NCI-NCIC-137 (Other Identifier)

I137

CAN-NCIC-IND137 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)