Clinical Trial: Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

Detailed Summary:

OBJECTIVES:

• Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).
• Compare the immune response in patients before and after treatment with these regimens.
• Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts.

• Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
• Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)
• Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.

NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2

• Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses
  Sponsor: National Cancer Institute (NCI)
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

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  Original Secondary Outcome:
  
  Information By: National Cancer Institute (NCI)
  

  Dates:
  Date Received: July 11, 2001
  Date Started: October 1999
  Date Completion:
  Last Updated: June 19, 2013
  Last Verified: August 2004