Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


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: 1. I (<.75 to 1.5 mm or Clark level III-T1-2N0M0-)—not eligible 2. II (1.5 to 4 mm or level IV-T3N0M0-)—eligible 3. III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)—eligible 4. IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)—eligible 5. 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 - Karnofsky Performance Status greater than or equal to 70 percent - No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease - No previous evidence of opportunistic infection - A minimum of 30 days must have elapsed since the completion of prior chemotherapy, immunotherapy or radiation therapy - Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0): 1. Hemoglobin >9.0 g/dl 2. Platelets > 100000/mm3 3. WBC > 3000/mm3 4. Absolute Neutrophil Count > 1000/mm3 - Positive skin test to common antigens (tetanus and candida) - Ability to give informed consent 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


NCT ID:

NCT00005617


Primary Contact:

Principal Investigator
John A Glaspy, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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