Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005971
Recruitment Status : Completed
First Posted : May 21, 2003
Last Update Posted : November 9, 2010
Information provided by:
Canadian Cancer Trials Group

Brief 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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: alvocidib Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
Study Start Date : July 2000
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN


  • Creatinine no greater than ULN


  • If history of cardiac disease, ejection fraction greater than 50%
  • No clinically significant cardiac symptomology


  • If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted
  • No clinically significant pulmonary symptomology


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other concurrent serious disease


Biologic therapy:

  • At least 4 weeks since prior adjuvant immunotherapy allowed
  • No prior immunotherapy for metastatic disease


  • No prior chemotherapy for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior adjuvant hormonal therapy


  • 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


  • At least 4 weeks since prior major surgery


  • No other concurrent anticancer therapy or investigational anticancer agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005971

  Show 50 Study Locations
Sponsors and Collaborators
NCIC Clinical Trials Group
Study Chair: Susan Burdette-Radoux, MD McGill Cancer Centre at McGill University

Publications of Results:
Burdette-Radoux S, Tozer RG, Lohmann R, et al.: NCIC CTG phase II study of flavopiridol in patients with previously untreated metastatic malignant melanoma (IND.137). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1382, 2002. Identifier: NCT00005971     History of Changes
Other Study ID Numbers: I137
CDR0000067955 ( Other Identifier: PDQ )
First Posted: May 21, 2003    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action