Vaccine Therapy in Treating Patients With Malignant Melanoma
NCT ID: NCT00128583
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2005-07-31
Brief Summary
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PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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polyvalent melanoma vaccine
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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CancerVax Corporation
INDUSTRY
Principal Investigators
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Linda Strause
Role: STUDY_CHAIR
CancerVax Corporation
Locations
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Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
CCOP - Dayton
Dayton, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Countries
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Other Identifiers
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CV-MMAIT-5-001
Identifier Type: -
Identifier Source: secondary_id
CDR0000439529
Identifier Type: -
Identifier Source: org_study_id