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Flavopiridol in Treating Patients With Metastatic Malignant Melanoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Flavopiridol in Treating Patients With Metastatic Malignant Melanoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Flavopiridol in Treating Patients With Metastatic Malignant Melanoma Clinical research trials and Flavopiridol in Treating Patients With Metastatic Malignant Melanoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Flavopiridol in Treating Patients With Metastatic Malignant Melanoma. Flavopiridol in Treating Patients With Metastatic Malignant Melanoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Flavopiridol in Treating Patients With Metastatic Malignant Melanoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Flavopiridol in Treating Patients With Metastatic Malignant Melanoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol in Treating Patients With Metastatic Malignant Melanoma  Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
For Condition: Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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.
Details: OBJECTIVES: I. Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma. II. Assess the toxicity of this treatment in these patients. III. Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBurdette-Radoux, Study Chair, National Cancer Institute of Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8
Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Canada
L'Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Penticton Regional Hospital
Penticton, British Columbia, V2A 3G6
Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8
Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB
Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2
Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4
Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5
Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5
Canada
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Hamilton and Disrict Urology Association
Hamilton, Ontario, L8N 1T8
Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3
Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8
Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Canada
Hopital du Saint-Sacrament, Quebec
Quebec City, Quebec, G1S 4L8
Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Canada
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, A1B 3V6
Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
North York General Hospital, Ontario
North York, Ontario, M2E 1K1
Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
London Health Sciences Centre
London, Ontario, N6A 4G5
Canada
Women's College Campus, Sunnybrook and Women's College Health Science Center
Toronto, Ontario, M5S 1B6
Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6
Canada
Scarborough Hospital - General Site
Scarborough, Ontario, M1P 2V5
Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Male Health Centre/CMX Research Inc.
Oakville, Ontario, L6H 3PI
Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Saint Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5
Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2
Canada
York County Hospital
Newmarket, Ontario, L3Y 2P9
Canada
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, P7A 7T1
Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8
Canada
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, H2W 1T8
Canada
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, P3E 5J1
Canada
McGill University
Montreal, Quebec, H2W 1S6
Canada
Humber River Regional Hospital
Weston, Ontario, M9N 1N8
Canada
Queen Elizabeth Hospital, PEI
Charlottetown, Prince Edward Island, C1A 8T5
Canada
Additional Information:
Study ID Numbers: CDR0000067955; CAN-NCIC-IND137,NCI-NCIC-137
Study Start Date: July 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005971
Other Stage 4 Melanoma Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
2. Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
3. Inhaled Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
4. CCI-779 in Treating Patients With Metastatic Melanoma
5. Cilengitide in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Quebec Clinical Trials
Other Montreal Clinical Trials
Flavopiridol in Treating Patients With Metastatic Malignant Melanoma
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