Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma. * Determine the safety and tolerability of this drug in these patients. * Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug. * Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment. Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 10 days after the last dose of study drug. PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.
Interventions
BIOLOGICALMKC1106-MT
Cancer Vaccine, Immunotherapy, 500 ug
Sponsors
Mannkind Corporation
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Must have tumor tissue available for determining antigen expression * At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry * HLA-A2 positive * No brain metastases unless completely resected or without evidence of disease after treatment PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * WBC at least 3,000/mm3 * Platelet count at least 75,000/mm3 * Hemoglobin at least 9 g/dL Hepatic: * SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin no greater than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal: * Creatinine no greater than 1.5 times ULN * Urea no greater than 2.6 times ULN Other: * Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No medical, sociological, or psychological impediments that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * At least 4 weeks since prior immunomodulatory drugs * No other concurrent immunotherapy * No concurrent immunomodulatory drugs Chemotherapy: * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * At least 4 weeks since prior systemic corticosteroids * No concurrent systemic corticosteroids Radiotherapy: * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 4 weeks since prior investigational drugs * No other concurrent investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study was to determine the immunological response of patients as measured by tetramer assay and to assess clinical response by LDH levels and radiological assessment of lesions. | — |
Countries
United States
Outcome results
None listed