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


Phase 2
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

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 SupportBethesda, Maryland  20892-1182