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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00064168 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor. Interleukin-2 and interleukin-12 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-12 with interleukin-2 may be a more effective treatment for metastatic melanoma.
PURPOSE: This randomized phase II trial is studying vaccine therapy, interleukin-12, and interleukin-2 to see how well they work compared to vaccine therapy and interleukin-12 in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: MART-1 antigen Drug: NA17-A antigen Drug: aldesleukin Drug: gp100 antigen Drug: recombinant MAGE-3.1 antigen Drug: recombinant interleukin-12 Drug: therapeutic autologous lymphocytes |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized Phase II Study Of Immunization With Mage-3/Melan-A/gp100/NA17 Peptide-Pulsed Autologous PBMC And rhIL-12 With Or Without Low Dose IL-2 In Patients With Metastatic Melanoma |
Estimated Enrollment: | 36 |
Study Start Date: | July 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 21 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response or stable disease may receive additional treatment sets of 3 courses for up to a total of 9 courses.
Patients are followed every 8 weeks until disease progression and then at least every 3 months thereafter.
PROJECTED ACCRUAL: A total of 36 patients (18 per treatment arm) will be accrued for this study within 1.25 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
No untreated brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No prior or active autoimmune disease including:
Systemic lupus erythematosus
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Thomas F. Gajewski, MD, PhD | University of Chicago |
Study ID Numbers: | CDR0000309519, UCCRC-11447A, NCI-1330 |
Study First Received: | July 8, 2003 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00064168 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Interleukin-12 Aldesleukin Interleukin-2 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Nevus Recurrence Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors |