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Vaccine Therapy in Treating Patients With Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVAC-hB7.1
canarypox-hIL-12 melanoma vaccine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 7, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003556
Brief Title
Vaccine Therapy in Treating Patients With Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
ALVAC-hB7.1
Intervention Type
Biological
Intervention Name(s)
canarypox-hIL-12 melanoma vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M. Conry, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Melanoma

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