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. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma. * Determine the clinical toxic effects of this vaccine in these patients. * Determine the safety of this vaccine in these patients. * Determine the clinical response of these patients to this vaccine. * Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations. Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine 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. Quality of life is assessed at baseline, at each vaccine administration, and at study completion. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma * Lesion(s) must be accessible to percutaneous injection * Measurable lesion(s) * At least 1.0 cm * Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed * At least 6 weeks since prior definitive therapy (surgery or radiotherapy) * No untreated or edematous metastatic brain lesions or leptomeningeal disease * No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Absolute granulocyte count at least 3,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * Direct bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications) * No hepatic insufficiency * No alcoholic cirrhosis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min * No renal insufficiency Cardiovascular: * No congestive heart failure * No serious cardiac arrhythmias * No evidence of recent prior myocardial infarction on EKG * No clinical coronary artery disease Pulmonary: * No chronic obstructive pulmonary disease Immunologic: * No prior eczema * HIV negative * No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds) * No clinical or laboratory evidence of an underlying immunosuppressive disorder * No active or chronic infections * No significant allergy or hypersensitivity to eggs Other: * No active seizure disorders * No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free * No evidence of bone marrow toxicity * No other concurrent medical illness that would preclude study * No other contraindications to vaccinia virus administration * No encephalitis * Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior vaccinia immunization required (e.g., smallpox vaccination) * More than 8 weeks since prior immunotherapy and recovered * No prior therapy with live vaccinia virus vector Chemotherapy: * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior systemic corticosteroids * No concurrent systemic corticosteroids * No concurrent steroids Radiotherapy: * See Disease Characteristics * More than 2 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered Other: * No concurrent immunosuppressive drugs
Countries
United States