Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
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Purpose
RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma Melanoma (Skin) |
Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: recombinant interleukin-12 Biological: sargramostim Biological: tyrosinase peptide Drug: alum adjuvant Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With Interleukin-12 With Alum or GM-CSF for Patients With Resected Stages IIB/C, III and IV Melanoma |
| Enrollment: | 60 |
| Study Start Date: | February 2002 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
- Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
- Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III or IV ocular or mucosal melanoma
- Resected or rendered disease-free
- HLA-A2.1-positive by standard cytotoxicity assay
Tumor tissue must be available for analysis of gp100 staining and tyrosinase and MART-1 expression by immunohistochemistry
- Must be positive for at least 1 antigen
- Failed, ineligible for, or refused prior interferon alfa
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9.0 g/dL
- No bleeding disorder
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times normal
- No coagulation disorder
- Hepatitis surface antigen B negative
- Hepatitis C negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No major cardiovascular illness
Pulmonary:
- No major respiratory illness
Immunologic:
- No prior uveitis
- No prior autoimmune inflammatory eye disease
- No immune hemolytic anemia
- No other active autoimmune disease
Other:
- HIV negative
- No major gastrointestinal illness
- No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
- No major systemic infection (e.g., pneumonia or sepsis)
- No other major medical illness
- No prior allergic reaction to Montanide ISA-51 or alum adjuvant
- No requirement for steroid therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides
Chemotherapy:
- At least 1 month since prior adjuvant chemotherapy for this disease
- No concurrent adjuvant chemotherapy
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- At least 1 month since prior radiotherapy for this disease
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 1 month since other prior therapy, including adjuvant therapy, for this disease
- No other concurrent therapy, including adjuvant therapy
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089 | |
| 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: | NCT00031733 History of Changes |
| Other Study ID Numbers: | CDR0000069220 (10M-01-1), LAC-USC-10M011, LAC-USC-IRB-013030, NCI-5506 |
| Study First Received: | March 8, 2002 |
| Last Updated: | October 20, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma |
stage II 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 Adjuvants, Immunologic Aluminum Hydroxide |
Aluminum sulfate Freund's Adjuvant Interleukin-12 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antacids Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013