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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan Burdette-Radoux, MD

Investigator Role:

Study Chair

Investigator Affiliation:

McGill Cancer Centre at McGill University

Authority:

United States: Federal Government

Study ID:

I137

NCT ID:

NCT00005971

Start Date:

July 2000

Completion Date:

December 2009

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma

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