MedPath

Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

Phase 2
Completed
Conditions
Melanoma (Skin)
Registration Number
NCT00005971
Lead Sponsor
NCIC Clinical 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (50)

York County Hospital

🇨🇦

Newmarket, Ontario, Canada

Women's College Campus, Sunnybrook and Women's College Health Science Center

🇨🇦

Toronto, Ontario, Canada

Credit Valley Hospital

🇨🇦

Mississauga, Ontario, Canada

Mount Sinai Hospital - Toronto

🇨🇦

Toronto, Ontario, Canada

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

Saint Joseph's Health Centre - Toronto

🇨🇦

Toronto, Ontario, Canada

Lakeridge Health Oshawa

🇨🇦

Oshawa, Ontario, Canada

Male Health Centre/CMX Research Inc.

🇨🇦

Oakville, Ontario, Canada

North York General Hospital, Ontario

🇨🇦

North York, Ontario, Canada

Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

Penticton Regional Hospital

🇨🇦

Penticton, British Columbia, Canada

G. Steinhoff Clinical Research

🇨🇦

Victoria, British Columbia, Canada

St. Paul's Hospital - Vancouver

🇨🇦

Vancouver, British Columbia, Canada

London Health Sciences Centre

🇨🇦

London, Ontario, Canada

Newfoundland Cancer Treatment and Research Foundation

🇨🇦

St. Johns, Newfoundland and Labrador, Canada

William Osler Health Centre

🇨🇦

Brampton, Ontario, Canada

St. Michael's Hospital - Toronto

🇨🇦

Toronto, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

🇨🇦

Windsor, Ontario, Canada

Maisonneuve-Rosemont Hospital

🇨🇦

Montreal, Quebec, Canada

Scarborough Hospital - General Site

🇨🇦

Scarborough, Ontario, Canada

Doctor Leon Richard Oncology Centre

🇨🇦

Moncton, New Brunswick, Canada

Saint John Regional Hospital

🇨🇦

Saint John, New Brunswick, Canada

Toronto East General Hospital

🇨🇦

Toronto, Ontario, Canada

McGill University

🇨🇦

Montreal, Quebec, Canada

Tom Baker Cancer Center - Calgary

🇨🇦

Calgary, Alberta, Canada

Prostate Centre at Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

Lethbridge Cancer Clinic

🇨🇦

Lethbridge, Alberta, Canada

Royal Victoria Hospital, Barrie

🇨🇦

Barrie, Ontario, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury

🇨🇦

Sudbury, Ontario, Canada

Saskatoon Cancer Centre

🇨🇦

Saskatoon, Saskatchewan, Canada

Humber River Regional Hospital

🇨🇦

Weston, Ontario, Canada

Centre Hospitalier de l'Universite' de Montreal

🇨🇦

Montreal, Quebec, Canada

Hotel Dieu de Montreal

🇨🇦

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

🇨🇦

Quebec City, Quebec, Canada

Nova Scotia Cancer Centre

🇨🇦

Halifax, Nova Scotia, Canada

Trillium Health Centre

🇨🇦

Mississauga, Ontario, Canada

Hamilton and Disrict Urology Association

🇨🇦

Hamilton, Ontario, Canada

Peterborough Oncology Clinic

🇨🇦

Peterborough, Ontario, Canada

Moncton Hospital

🇨🇦

Moncton, New Brunswick, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay

🇨🇦

Thunder Bay, Ontario, Canada

Queen Elizabeth Hospital, PEI

🇨🇦

Charlottetown, Prince Edward Island, Canada

Ottawa Regional Cancer Centre

🇨🇦

Ottawa, Ontario, Canada

Hopital du Saint-Sacrament, Quebec

🇨🇦

Quebec City, Quebec, Canada

Toronto Sunnybrook Regional Cancer Centre

🇨🇦

Toronto, Ontario, Canada

Allan Blair Cancer Centre

🇨🇦

Regina, Saskatchewan, Canada

Hotel Dieu Health Sciences Hospital - Niagara

🇨🇦

St. Catharines, Ontario, Canada

CHUS-Hopital Fleurimont

🇨🇦

Fleurimont, Quebec, Canada

Hopital Du Sacre-Coeur de Montreal

🇨🇦

Montreal, Quebec, Canada

L'Hopital Laval

🇨🇦

Ste-Foy, Quebec, Canada

Centre Hospitalier Regional de Lanaudiere

🇨🇦

Joliette, Quebec, Canada

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