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

Melanoma (Skin) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00019669
• Other study ID #: CDR0000066961
• Secondary ID: NCI-99-C-0044NCI
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 19, 2013
• Start date: October 1999
• Est. completion date: October 2007

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001800

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven metastatic melanoma that has failed standard treatment

• Measurable disease

• HLA-A-201 positive

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC = 3,000/mm^3

• Platelet count = 90,000/mm^3

• No coagulation disorders

Hepatic:

• Bilirubin = 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)

• AST/ALT < 2 times normal

• Hepatitis B surface antigen negative

Renal:

• Creatinine = 2.0 mg/dL

Cardiovascular:

• No major cardiovascular disease

• No cardiac ischemia by a stress thallium test or other comparable test*

• No myocardial infarction*

• No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• aldesleukin

• fowlpox virus vaccine vector

• gp100 antigen

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation