Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma
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Purpose
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells.
PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: recombinant interleukin-12 Biological: tyrosinase peptide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma |
| Enrollment: | 48 |
| Study Start Date: | November 1998 |
| Study Completion Date: | September 2004 |
| Primary Completion Date: | November 1999 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma.
OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy (immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2 treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks, then every 3 months for 2 years after resection, then every 6 months for 3 years, and then yearly if without evidence of disease.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of gp100/tyrosinase expression Detectable expression of one or the other antigen not required
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second malignancy within the past 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery
Contacts and Locations| United States, California | |
| Beckman Research Institute, City of Hope | |
| Duarte, California, United States, 91010 | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033-0800 | |
| Study Chair: | Jeffrey S. Weber, MD, PhD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00003339 History of Changes |
| Other Study ID Numbers: | CDR0000066310 (10M-97-3), LAC-USC-10M973, NCI-G98-1432, NCI-T97-0099 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
recurrent intraocular melanoma stage III melanoma stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
Freund's Adjuvant Interleukin-12 Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013