Expired Study
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New York, New York 10032


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Howard L. Kaufman, MD
Herbert Irving Comprehensive Cancer Center

Backup Contact:


Location Contact:

New York, New York 10032
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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