Vaccine Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003556
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: February 2013
  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.


Condition Intervention Phase
Melanoma (Skin)
Biological: ALVAC-hB7.1
Biological: canarypox-hIL-12 melanoma vaccine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 15
Study Start Date: January 1999
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Biological: ALVAC-hB7.1 Biological: canarypox-hIL-12 melanoma vaccine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003556

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Investigators
Study Chair: Robert M. Conry, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003556     History of Changes
Other Study ID Numbers: NCI-2012-02274, UAB-9705, NCI-T97-0046, CDR0000066619
Study First Received: November 1, 1999
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 28, 2014