NCT00019669

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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 description

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 beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy. PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	fowlpox virus vaccine vector
BIOLOGICAL	gp100 antigen

Timeline

• Start date: 1999-10-01
• Completion: 2007-10-01
• First posted: 2003-01-27
• Last updated: 2013-06-20

Locations

1 site across 1 country: United States