Phase Ib Trial of Intratumoral Injection of a Recombinant Canarypox Virus Encoding Human B7.1 (ALVAC-hB7.1) or a Combination of ALVAC-hB7.1 and a Recombinant Canarypox Virus Encoding Human Interleukin 12 (ALVAC-hIL-12) in Patients With Surgically Incurable Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Phase Ib Trial of Intratumoral Injection of a Recombinant Canarypox Virus Encoding Human B7.1 (ALVAC-hB7.1) or a Combination of ALVAC-hB7.1 and a Recombinant Canarypox Virus Encoding Human Interleukin 12 (ALVAC-hIL-12) in Patients With Surgically Incurable Melanoma
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.
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)
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Robert M. Conry, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02274
NCT ID:
NCT00003556
Start Date:
January 1999
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| University of Alabama Comprehensive Cancer Center | Birmingham, Alabama 35294 |
