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Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005971
First Posted: May 21, 2003
Last Update Posted: November 9, 2010
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.
Information provided by:
Canadian Cancer Trials Group
  Purpose

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 Intervention Phase
Melanoma (Skin) Drug: alvocidib Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Canadian Cancer Trials Group:

Study Start Date: July 2000
Study Completion Date: December 2009
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00005971


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

Publications:
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.

ClinicalTrials.gov Identifier: NCT00005971     History of Changes
Other Study ID Numbers: I137
CAN-NCIC-IND137
NCI-NCIC-137
CDR0000067955 ( Other Identifier: PDQ )
First Submitted: July 5, 2000
First Posted: May 21, 2003
Last Update Posted: November 9, 2010
Last Verified: March 2010

Keywords provided by Canadian Cancer Trials Group:
stage IV melanoma

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