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Vaccine Therapy in Treating Patients With Malignant Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
polyvalent melanoma vaccine
Sponsored by
CancerVax Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter PATIENT CHARACTERISTICS: Age 18 to 80 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Comprehensive Cancer Center at Desert Regional Medical Center
  • John Wayne Cancer Institute at Saint John's Health Center
  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • CCOP - Dayton
  • Abramson Cancer Center of the University of Pennsylvania
  • Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
  • M.D. Anderson Cancer Center at University of Texas
  • LDS Hospital
  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Princess Alexandra Hospital

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Full Information

First Posted
August 8, 2005
Last Updated
December 18, 2013
Sponsor
CancerVax Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00128583
Brief Title
Vaccine Therapy in Treating Patients With Malignant Melanoma
Official Title
Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CancerVax Corporation

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
Detailed Description
OBJECTIVES: Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™). OUTLINE: This is an open-label, multicenter study. Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™). After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
polyvalent melanoma vaccine
Primary Outcome Measure Information:
Title
Response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter PATIENT CHARACTERISTICS: Age 18 to 80 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Strause
Organizational Affiliation
CancerVax Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at Desert Regional Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
John Wayne Cancer Institute at Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33804-1057
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Malignant Melanoma

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