Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Steven A. Rosenberg, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Federal Government
Study ID:
CDR0000066961
NCT ID:
NCT00019669
Start Date:
October 1999
Completion Date:
October 2007
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
