Clincosm LogoSign in Get a demo

Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

Sponsor
NCIC Clinical Trials Group (Other)
Overall Status
Completed
CT.gov ID
NCT00005971
Collaborator
(none)
17
Enrollment
50
Locations
113.6
Actual Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
Actual Study Start Date :
Jul 4, 2000
Actual Primary Completion Date :
Aug 24, 2001
Actual Study Completion Date :
Dec 21, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    2 Lethbridge Cancer Clinic Lethbridge Alberta Canada T1J 1W5
    3 Penticton Regional Hospital Penticton British Columbia Canada V2A 3G6
    4 Prostate Centre at Vancouver General Hospital Vancouver British Columbia Canada V5Z 3J5
    5 St. Paul's Hospital - Vancouver Vancouver British Columbia Canada V6Z 1Y6
    6 G. Steinhoff Clinical Research Victoria British Columbia Canada V8V 3N1
    7 Moncton Hospital Moncton New Brunswick Canada E1C 6ZB
    8 Doctor Leon Richard Oncology Centre Moncton New Brunswick Canada E1C 8X3
    9 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    10 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
    11 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    12 Royal Victoria Hospital, Barrie Barrie Ontario Canada L4M 6M2
    13 William Osler Health Centre Brampton Ontario Canada L6W 2Z8
    14 Hamilton and Disrict Urology Association Hamilton Ontario Canada L8N 1T8
    15 London Health Sciences Centre London Ontario Canada N6A 4G5
    16 Trillium Health Centre Mississauga Ontario Canada L5B 1B8
    17 Credit Valley Hospital Mississauga Ontario Canada L5M 2N1
    18 York County Hospital Newmarket Ontario Canada L3Y 2P9
    19 North York General Hospital, Ontario North York Ontario Canada M2E 1K1
    20 Male Health Centre/CMX Research Inc. Oakville Ontario Canada L6H 3PI
    21 Lakeridge Health Oshawa Oshawa Ontario Canada L1G 2B9
    22 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4
    23 Peterborough Oncology Clinic Peterborough Ontario Canada K9H 7B6
    24 Scarborough Hospital - General Site Scarborough Ontario Canada M1P 2V5
    25 Hotel Dieu Health Sciences Hospital - Niagara St. Catharines Ontario Canada L2R 5K3
    26 Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario Canada P3E 5J1
    27 Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario Canada P7A 7T1
    28 Toronto East General Hospital Toronto Ontario Canada M4C 3E7
    29 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5
    30 St. Michael's Hospital - Toronto Toronto Ontario Canada M5B 1W8
    31 Mount Sinai Hospital - Toronto Toronto Ontario Canada M5G 1X5
    32 Toronto General Hospital Toronto Ontario Canada M5G 2C4
    33 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    34 Women's College Campus, Sunnybrook and Women's College Health Science Center Toronto Ontario Canada M5S 1B6
    35 Saint Joseph's Health Centre - Toronto Toronto Ontario Canada M6R 1B5
    36 Humber River Regional Hospital Weston Ontario Canada M9N 1N8
    37 Cancer Care Ontario - Windsor Regional Cancer Centre Windsor Ontario Canada N8W 2X3
    38 Queen Elizabeth Hospital, PEI Charlottetown Prince Edward Island Canada C1A 8T5
    39 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    40 Centre Hospitalier Regional de Lanaudiere Joliette Quebec Canada J6E 6J2
    41 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4
    42 McGill University Montreal Quebec Canada H2W 1S6
    43 Centre Hospitalier de l'Universite' de Montreal Montreal Quebec Canada H2W 1T8
    44 Hotel Dieu de Montreal Montreal Quebec Canada H2W 1T8
    45 Hopital Du Sacre-Coeur de Montreal Montreal Quebec Canada H4J 1C5
    46 Centre Hospitalier Universitaire de Quebec Quebec City Quebec Canada G1R 2J6
    47 Hopital du Saint-Sacrament, Quebec Quebec City Quebec Canada G1S 4L8
    48 L'Hopital Laval Ste-Foy Quebec Canada G1V 4G5
    49 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    50 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • NCIC Clinical Trials Group

    Investigators

    • Study Chair: Susan Burdette-Radoux, MD, McGill Cancer Centre at McGill University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NCIC Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT00005971
    Other Study ID Numbers:
    • I137
    • CAN-NCIC-IND137
    • NCI-NCIC-137
    • CDR0000067955
    First Posted:
    May 21, 2003
    Last Update Posted:
    Apr 9, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by NCIC Clinical Trials Group
    stage IV melanoma
    Additional relevant MeSH terms:
    Melanoma
    Alvocidib

    Study Results

    No Results Posted as of Apr 9, 2020