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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 CenterBirmingham, Alabama  35294