Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00005971
First received: July 5, 2000
Last updated: November 7, 2010
Last verified: March 2010
  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 NCIC Clinical 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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
Study First Received: July 5, 2000
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage IV melanoma

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

ClinicalTrials.gov processed this record on August 27, 2014