Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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
-
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):
- Hemoglobin >9.0 g/dl
- Platelets > 100000/mm3
- WBC > 3000/mm3
- 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
Trial design
0 participants in 6 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal