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.

Condition	Intervention	Phase
stage III melanoma	Drug: polyvalent melanoma vaccine  Procedure: biological response modifier therapy  Procedure: tumor cell derivative vaccine  Procedure: vaccine therapy	Phase II

Further Study Details: 

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, single arm, 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.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00128583

California
      CancerVax Corporation, Carlsbad,  California,  92008,  United States; Recruiting
      Comprehensive Cancer Center at Desert Regional Medical Center, Palm Springs,  California,  92262,  United States; Recruiting
      John Wayne Cancer Institute at Saint John''''s Health Center, Santa Monica,  California,  90404,  United States; Recruiting
Florida
      Lakeland Regional Cancer Center at Lakeland Regional Medical Center, Lakeland,  Florida,  33804-1057,  United States; Recruiting
Pennsylvania
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Utah
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States; Recruiting
Australia, New South Wales
      Sydney Cancer Centre at Royal Prince Alfred Hospital, Sydney,  New South Wales,  2050,  Australia; Recruiting
Australia, Queensland
      Princess Alexandra Hospital, Brisbane,  Queensland,  4102,  Australia; Recruiting

Study chairs or principal investigators

Linda Strause,  Study Chair,  CancerVax Corporation   

Study ID Numbers:  CDR0000439529; CV-MMAIT-5-001
Last Updated:  August 22, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128583
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23