Vaccine Therapy in Treating Patients With Melanoma

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Melanoma (Skin)

Treatments

Biological: ALVAC-hB7.1

Biological: canarypox-hIL-12 melanoma vaccine

Study type

Interventional

Funder types

NIH

Identifiers

NCT00003556

NCI-2012-02274

NCI-T97-0046

UAB-9705

CDR0000066619 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)