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Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005971
  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 II

Study Type: Interventional
Study Design: 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 National Cancer Institute (NCI):

Study Start Date: July 2000
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005971

  Hide Study Locations
Locations
Canada, Alberta
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada, T1J 1W5
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada, V8V 3N1
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 3J5
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6ZB
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada, N8W 2X3
Peterborough Oncology Clinic
Peterborough, Ontario, Canada, K9H 7B6
Hamilton and Disrict Urology Association
Hamilton, Ontario, Canada, L8N 1T8
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada, L2R 5K3
Humber River Regional Hospital
Weston, Ontario, Canada, M9N 1N8
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 2B9
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Male Health Centre/CMX Research Inc.
Oakville, Ontario, Canada, L6H 3PI
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada, M5G 1X5
North York General Hospital, Ontario
North York, Ontario, Canada, M2E 1K1
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada, L4M 6M2
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, Canada, M6R 1B5
Scarborough Hospital - General Site
Scarborough, Ontario, Canada, M1P 2V5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
William Osler Health Centre
Brampton, Ontario, Canada, L6W 2Z8
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, Canada, M5S 1B6
York County Hospital
Newmarket, Ontario, Canada, L3Y 2P9
Canada, Prince Edward Island
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Canada, Quebec
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada, J6E 6J2
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8
L'Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
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 RC, Quirt I, Ernst DS, Walsh W, Wainman N, Colevas AD, Eisenhauer EA. Phase II trial of flavopiridol, a cyclin dependent kinase inhibitor, in untreated metastatic malignant melanoma. Invest New Drugs. 2004 Aug;22(3):315-22.
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.

Study ID Numbers: CDR0000067955, CAN-NCIC-IND137, NCI-NCIC-137
Study First Received: July 5, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00005971     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma

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

ClinicalTrials.gov processed this record on November 25, 2009