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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
July 5, 2000
May 21, 2003
November 9, 2010
July 2000
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Complete list of historical versions of study NCT00005971 on ClinicalTrials.gov Archive Site
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Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Melanoma (Skin)
Drug: alvocidib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2009
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00005971
I137
CAN-NCIC-IND137
NCI-NCIC-137
CDR0000067955 ( Other Identifier: PDQ )
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NCIC Clinical Trials Group
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Study Chair: Susan Burdette-Radoux, MD McGill Cancer Centre at McGill University
Canadian Cancer Trials Group
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP