Vaccine Therapy in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: recombinant vaccinia-TRICOM vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant vaccinia-TRICOM vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma