Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

NCT ID: NCT00005971

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-04
• Study Completion Date: 2009-12-21

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.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

alvocidib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Burdette-Radoux, MD

Role: STUDY_CHAIR

McGill Cancer Centre at McGill University

Locations

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Lethbridge Cancer Clinic

Lethbridge, Alberta, Canada

Penticton Regional Hospital

Penticton, British Columbia, Canada

Prostate Centre at Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, Canada

G. Steinhoff Clinical Research

Victoria, British Columbia, Canada

Moncton Hospital

Moncton, New Brunswick, Canada

Doctor Leon Richard Oncology Centre

Moncton, New Brunswick, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Newfoundland Cancer Treatment and Research Foundation

St. John's, Newfoundland and Labrador, Canada

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Royal Victoria Hospital, Barrie

Barrie, Ontario, Canada

William Osler Health Centre

Brampton, Ontario, Canada

Northeastern Ontario Regional Cancer Centre, Sudbury

Greater Sudbury, Ontario, Canada

Hamilton and Disrict Urology Association

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Trillium Health Centre

Mississauga, Ontario, Canada

Credit Valley Hospital

Mississauga, Ontario, Canada

York County Hospital

Newmarket, Ontario, Canada

North York General Hospital, Ontario

North York, Ontario, Canada

Male Health Centre/CMX Research Inc.

Oakville, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Ottawa Regional Cancer Centre

Ottawa, Ontario, Canada

Peterborough Oncology Clinic

Peterborough, Ontario, Canada

Scarborough Hospital - General Site

Scarborough Village, Ontario, Canada

Hotel Dieu Health Sciences Hospital - Niagara

St. Catharines, Ontario, Canada

Northwestern Ontario Regional Cancer Centre, Thunder Bay

Thunder Bay, Ontario, Canada

Toronto East General Hospital

Toronto, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

St. Michael's Hospital - Toronto

Toronto, Ontario, Canada

Mount Sinai Hospital - Toronto

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

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

Toronto, Ontario, Canada

Saint Joseph's Health Centre - Toronto

Toronto, Ontario, Canada

Humber River Regional Hospital

Weston, Ontario, Canada

Cancer Care Ontario - Windsor Regional Cancer Centre

Windsor, Ontario, Canada

Queen Elizabeth Hospital, PEI

Charlottetown, Prince Edward Island, Canada

CHUS-Hopital Fleurimont

Fleurimont, Quebec, Canada

Centre Hospitalier Regional de Lanaudiere

Joliette, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Centre Hospitalier de l'Universite' de Montreal

Montreal, Quebec, Canada

Hotel Dieu de Montreal

Montreal, Quebec, Canada

Hopital Du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, Canada

Hopital du Saint-Sacrament, Quebec

Québec, Quebec, Canada

L'Hopital Laval

Ste-Foy, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 15122079 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

CAN-NCIC-IND137

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-NCIC-137

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067955

Identifier Type: OTHER

Identifier Source: secondary_id

I137

Identifier Type: -

Identifier Source: org_study_id