A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Jonsson Comprehensive Cancer Center
- Locations
- 1
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.
Detailed Description
OBJECTIVES: * Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma. * Determine the immunological and clinical responses in this patient population after this therapy. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28. Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults over the age of 18 with malignant melanoma.
- •HLA-A2.1 positive and express MART-1, as assessed by either RT-PCR or by immunohistochemistry
- •Tumor stages T3N0M0 or greater are eligible for this trial according to the following:
- •I (\<.75 to 1.5 mm or Clark level III-T1-2N0M0-)-not eligible
- •II (1.5 to 4 mm or level IV-T3N0M0-)-eligible
- •III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible
- •IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible
- •Relapsed melanoma-eligible
- •Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed \>30 days prior to enrollment
- •Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment
Exclusion Criteria
- •Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test
- •Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment
- •HIV-infected patients
- •Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk
- •Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study)
- •Patients with organ allografts
- •Uncontrolled CNS metastasis. Patients with CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth
Outcomes
Primary Outcomes
Not specified