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| Sponsored by: |
CancerVax Corporation |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00128583 |
Purpose
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 |
|---|---|---|
|
Melanoma (Skin) |
Drug: polyvalent melanoma vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™ |
| Study Start Date: | July 2005 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, California | |
| Comprehensive Cancer Center at Desert Regional Medical Center | |
| Palm Springs, California, United States, 92262 | |
| John Wayne Cancer Institute at Saint John's Health Center | |
| Santa Monica, California, United States, 90404 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33804-1057 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| LDS Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| Australia, New South Wales | |
| Sydney Cancer Centre at Royal Prince Alfred Hospital | |
| Sydney, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
| Princess Alexandra Hospital | |
| Brisbane, Queensland, Australia, 4102 | |
| Study Chair: | Linda Strause | CancerVax Corporation |
More Information
| Study ID Numbers: | CDR0000439529, CV-MMAIT-5-001 |
| Study First Received: | August 8, 2005 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00128583 |
| Health Authority: | United States: Federal Government |
|
stage III melanoma |
|
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
|
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
