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

NCT ID: NCT00019669

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2007-10-31

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 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)

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

fowlpox virus vaccine vector

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Pulmonary:

• No major respiratory disease
• No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2

Immunologic:

• No autoimmune disease
• No known immunodeficiency disease
• No primary or secondary immunodeficiency
• No allergy to eggs
• No active systemic infections
• HIV negative

Other:

• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other active major medical illness* NOTE: *In order to be eligible to receive IL-2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior gp100 vaccination

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• Not specified

Surgery:

• Prior surgery for the malignancy allowed

Other:

• At least 3 weeks since other prior therapy for the malignancy

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

References

Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Topalian SL, Sherry RM, Restifo NP, Wunderlich JR, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, Gritz L, Panicali DL, White DE. Recombinant fowlpox viruses encoding the anchor-modified gp100 melanoma antigen can generate antitumor immune responses in patients with metastatic melanoma. Clin Cancer Res. 2003 Aug 1;9(8):2973-80.

Reference Type: BACKGROUND

PMID: 12912944 (View on PubMed)

Other Identifiers

NCI-99-C-0044

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0088

Identifier Type: -

Identifier Source: secondary_id

CDR0000066961

Identifier Type: -

Identifier Source: org_study_id

NCT00001800

Identifier Type: -

Identifier Source: nct_alias