Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

NCT00005971 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: I137CAN-NCIC-IND137NCI-NCIC-137CDR0000067955
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 50

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Interventions

alvocidib DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (50)

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Lethbridge Cancer Clinic

Lethbridge, Alberta, T1J 1W5, Canada

Location

Penticton Regional Hospital

Penticton, British Columbia, V2A 3G6, Canada

Location

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 3J5, Canada

Location

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

G. Steinhoff Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

Moncton Hospital

Moncton, New Brunswick, E1C 6ZB, Canada

Location

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, E1C 8X3, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Royal Victoria Hospital, Barrie

Barrie, Ontario, L4M 6M2, Canada

Location

William Osler Health Centre

Brampton, Ontario, L6W 2Z8, Canada

Location

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Hamilton and Disrict Urology Association

Hamilton, Ontario, L8N 1T8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

York County Hospital

Newmarket, Ontario, L3Y 2P9, Canada

Location

North York General Hospital, Ontario

North York, Ontario, M2E 1K1, Canada

Location

Male Health Centre/CMX Research Inc.

Oakville, Ontario, L6H 3PI, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Peterborough Oncology Clinic

Peterborough, Ontario, K9H 7B6, Canada

Location

Scarborough Hospital - General Site

Scarborough Village, Ontario, M1P 2V5, Canada

Location

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, L2R 5K3, Canada

Location

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, P7A 7T1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital - Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital - Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

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

Toronto, Ontario, M5S 1B6, Canada

Location

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Humber River Regional Hospital

Weston, Ontario, M9N 1N8, Canada

Location

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, C1A 8T5, Canada

Location

CHUS-Hopital Fleurimont

Fleurimont, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, J6E 6J2, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Centre Hospitalier de l'Universite' de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Hotel Dieu de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, G1S 4L8, Canada

Location

L'Hopital Laval

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

• 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. doi: 10.1023/B:DRUG.0000026258.02846.1c.

  PMID: 15122079 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Melanoma

Interventions

alvocidib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susan Burdette-Radoux, MD

  McGill Cancer Centre at McGill University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: May 21, 2003
• Study Start: July 4, 2000
• Primary Completion: August 24, 2001
• Study Completion: December 21, 2009
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (50)