Vaccine Therapy in Treating Patients With Melanoma

NCT ID: NCT00003556

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31

Brief Summary

Phase I trial to study the effectiveness of vaccine therapy in treating patients with melanoma that cannot be treated with surgery. Vaccines may make the body build an immune response that may kill tumor cells. Combining more than one vaccine may kill more tumor cells.

Detailed Description

OBJECTIVES:

I. Determine the toxic effects associated with ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 in patients with surgically incurable melanoma.

II. Characterize the inflammatory and lymphokine response to this regimen in these patients.

III. Examine the extent of nodule regression, humoral immune response, and cytolytic T cell activity with this regimen in these patients.

OUTLINE: This is a dose escalation study of ALVAC-hB7.1

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Patients are followed at 1, 2, 4, 8, 11, 15, 22, and 43 days after the first vaccination.

Conditions

Melanoma (Skin)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive ALVAC-hB7.1 alone or combined with ALVAC-hIL-12 intratumorally on days 1, 4, 8, and 11. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of ALVAC-hB7.1. The maximum tolerated dose is defined as the dose of ALVAC-hB7.1 at which no more than 1 of 5 patients experiences dose limiting toxicity.

Group Type: EXPERIMENTAL

ALVAC-hB7.1

Intervention Type: BIOLOGICAL

canarypox-hIL-12 melanoma vaccine

Intervention Type: BIOLOGICAL

Interventions

ALVAC-hB7.1

Intervention Type: BIOLOGICAL

canarypox-hIL-12 melanoma vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed melanoma that is surgically incurable
• At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection
• If only one accessible lesion is available, it must be at least 2 cm
• If two or more accessible lesions exist, then none of them are required to be at least 2 cm

PATIENT CHARACTERISTICS:

• Age: Over 18
• Performance status: ECOG 0-2
• Life expectancy: Greater than 3 months
• Leukocyte count at least 3,000/mm3
• Platelet count at least 120,000/mm3
• SGOT and alkaline phosphatase less than 5 times normal
• Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis)
• BUN less than 40 mg/dL
• Creatinine less than 2.5 mg/dL
• No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias
• Not positive for hepatitis B virus
• Not positive for HIV
• No history of allergy to vaccinia virus
• No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No underlying immunodeficiency disorder

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior biologic therapy (e.g., interferon or IL-2)
• At least 30 days since prior chemotherapy
• No concurrent steroids
• At least 30 days since prior radiotherapy
• Prior radiotherapy to no greater than 50% of nodal groups
• No prior splenectomy
• No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert M. Conry, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

UAB-9705

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0046

Identifier Type: -

Identifier Source: secondary_id

CDR0000066619

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02274

Identifier Type: -

Identifier Source: org_study_id