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Vaccine Therapy in Treating Patients With Malignant Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00128583
First received: August 8, 2005
Last updated: February 6, 2009
Last verified: September 2005
History of Changes

August 8, 2005
February 6, 2009
July 2005
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Response [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00128583 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Malignant Melanoma
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.

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.
Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
Biological: polyvalent melanoma vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00128583
CDR0000439529, CV-MMAIT-5-001
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CancerVax Corporation
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Study Chair: Linda Strause CancerVax Corporation
National Cancer Institute (NCI)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP