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| 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 |
| Study Start Date: | July 2000 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic malignant melanoma not amenable to standard curative therapies
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study 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 | |
| Study Chair: | Susan Burdette-Radoux, MD | McGill Cancer Centre at McGill University |
More Information
| 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 |
|
stage IV melanoma |
|
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 |