Vaccine Therapy in Treating Patients With Metastatic Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
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Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma.
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Determine the clinical toxic effects of this vaccine in these patients.
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Determine the safety of this vaccine in these patients.
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Determine the clinical response of these patients to this vaccine.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma
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Lesion(s) must be accessible to percutaneous injection
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Measurable lesion(s)
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At least 1.0 cm
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Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed
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At least 6 weeks since prior definitive therapy (surgery or radiotherapy)
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No untreated or edematous metastatic brain lesions or leptomeningeal disease
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No ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
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WBC at least 3,000/mm3
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Platelet count at least 100,000/mm3
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Absolute granulocyte count at least 3,000/mm3
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Hemoglobin at least 10 g/dL
Hepatic:
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Direct bilirubin no greater than 1.5 mg/dL
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Transaminases no greater than 2 times upper limit of normal (ULN)
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Alkaline phosphatase no greater than 2 times ULN
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No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications)
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No hepatic insufficiency
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No alcoholic cirrhosis
Renal:
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Creatinine no greater than 2.0 mg/dL OR
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Creatinine clearance at least 60 mL/min
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No renal insufficiency
Cardiovascular:
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No congestive heart failure
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No serious cardiac arrhythmias
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No evidence of recent prior myocardial infarction on EKG
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No clinical coronary artery disease
Pulmonary:
- No chronic obstructive pulmonary disease
Immunologic:
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No prior eczema
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HIV negative
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No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds)
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No clinical or laboratory evidence of an underlying immunosuppressive disorder
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No active or chronic infections
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No significant allergy or hypersensitivity to eggs
Other:
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No active seizure disorders
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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
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No evidence of bone marrow toxicity
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No other concurrent medical illness that would preclude study
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No other contraindications to vaccinia virus administration
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No encephalitis
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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
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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Prior vaccinia immunization required (e.g., smallpox vaccination)
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More than 8 weeks since prior immunotherapy and recovered
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No prior therapy with live vaccinia virus vector
Chemotherapy:
- More than 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
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At least 4 weeks since prior systemic corticosteroids
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No concurrent systemic corticosteroids
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No concurrent steroids
Radiotherapy:
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See Disease Characteristics
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More than 2 weeks since prior radiotherapy and recovered
Surgery:
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See Disease Characteristics
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More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered
Other:
- No concurrent immunosuppressive drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Herbert Irving Comprehensive Cancer Center
- National Cancer Institute (NCI)
Investigators
- Study Chair: Howard L. Kaufman, MD, Herbert Irving Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068831
- CPMC-IRB-14387
- AECM-01-003
- NCI-3353