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Vaccine Therapy in Treating Patients With Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003556
First Posted: August 17, 2004
Last Update Posted: February 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003556


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

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 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: November 1, 1999
First Posted: August 17, 2004
Last Update Posted: February 8, 2013
Last Verified: February 2013

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs