Vaccine Therapy in Treating Patients With Malignant Melanoma

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00128583
• Other study ID #: CDR0000439529
• Secondary ID: CV-MMAIT-5-001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 8, 2005
• Last updated: December 18, 2013
• Start date: July 2005

Study information

• Verified date: September 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• polyvalent melanoma vaccine

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Sydney Cancer Centre at Royal Prince Alfred Hospital	Sydney	New South Wales
United States	Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	CCOP - Dayton	Dayton	Ohio
United States	M.D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Comprehensive Cancer Center at Desert Regional Medical Center	Palm Springs	California
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	LDS Hospital	Salt Lake City	Utah
United States	John Wayne Cancer Institute at Saint John's Health Center	Santa Monica	California
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CancerVax Corporation

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response			No