Vaccine Therapy in Treating Patients With Malignant Melanoma

December 18, 2013 updated by: CancerVax Corporation

Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Sydney Cancer Centre at Royal Prince Alfred Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Comprehensive Cancer Center at Desert Regional Medical Center
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute at Saint John's Health Center
    • Florida
      • Lakeland, Florida, United States, 33804-1057
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Ohio
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • Abramson Cancer Center of the University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CancerVax Corporation

Investigators

  • Study Chair: Linda Strause, CancerVax Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

August 8, 2005

First Submitted That Met QC Criteria

August 8, 2005

First Posted (Estimate)

August 10, 2005

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000439529
  • CV-MMAIT-5-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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