Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
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Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201 |
| Study Start Date: | April 1999 |
OBJECTIVES:
- Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
- Determine the efficacy of these peptides in patients who cannot receive IL-2.
- Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
- Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
- Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
- Compare the toxic effects of these regimens in these patients.
OUTLINE: This is a partially randomized study.
Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.
Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
- Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
- Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
- Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
- Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.
Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma that has failed standard therapy
- Measurable disease
- HLA-A0201 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
- No coagulation disorder
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No major cardiovascular disease
- If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only
Pulmonary:
- No major respiratory disease
Other:
- Not pregnant
- Fertile patients must use effective contraception
- HIV negative
- No active systemic infection
- No autoimmune disease or immunodeficiency disease
- No primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic therapy
- No prior MART-1 antigen immunization
Chemotherapy:
- At least 3 weeks since prior chemotherapy
Endocrine therapy:
- At least 3 weeks since prior endocrine therapy
- No concurrent steroid therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy
Surgery:
- Prior surgery allowed
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00019721 History of Changes |
| Obsolete Identifiers: | NCT00001808 |
| Other Study ID Numbers: | CDR0000067051, NCI-99-C-0092, NCI-T99-0033 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Freund's Adjuvant Aldesleukin |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013