Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT ID: NCT00022568

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

recombinant vaccinia-TRICOM vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Howard L. Kaufman, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-14387

Identifier Type: -

Identifier Source: secondary_id

AECM-01-003

Identifier Type: -

Identifier Source: secondary_id

NCI-3353

Identifier Type: -

Identifier Source: secondary_id

CDR0000068831

Identifier Type: -

Identifier Source: org_study_id