Flavopiridol in Treating Patients With Metastatic Malignant Melanoma

Phase 2

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00005971
• Lead Sponsor: NCIC Clinical Trials Group

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.

Study Timeline

• Study Start: 2000-07-04
• Study First Submitted: 2000-07-05
• Primary Completion: 2001-08-24
• Study First Submitted QC: 2003-05-20
• Study First Posted: 2003-05-21
• Study Completion: 2009-12-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (50)

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. Johns, Newfoundland and Labrador, Canada

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