Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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.


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)


Study is Available At:


Original ID:

NCI-2012-02274


NCT ID:

NCT00003556


Secondary ID:

UAB-9705


Study Acronym:


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 Incurabl


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:Robert M. Conry, MD
Study Chair
University of Alabama at Birmingham

Study Dates

Start Date:January 1999
Primary Completion Date:May 2001
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 7, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:ALVAC-hB7.1
Arm Name:Arm I
Intervention Type:Biological
Name:canarypox-hIL-12 melanoma vaccine
Arm Name:Arm I

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I
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.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.