Know Cancer

or
forgot password

PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN


OBJECTIVES: I. Evaluate the toxicity, immunologic reactivity, and possible therapeutic
efficacy of immunization with recombinant fowlpox virus encoding the gp100 melanoma antigen
administered alone or with interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study. Patients receive recombinant fowlpox virus
encoding the gp100 melanoma antigen (FPV-gp100) IV or intramuscularly to rotating sites or
fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations.
Treatment continues for a maximum of 2 courses in the absence of disease progression.
Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients develop dose-limiting toxicity. Patients in 3 of 5 cohorts also receive
interleukin-2 (IL-2) within 12 hours of FPV-gp100. One cohort receives IL-2 subcutaneously
daily on days 1-5 and days 8-12. A second cohort receives low-dose IL-2 IV over 15 minutes
every 8 hours on days 2-8. A third cohort receives high-dose IL-2 IV over 15 minutes every 8
hours on days 2-6. Patients in cohorts 4 and 5 receive FPV-gp100 alone and, if no response
is observed after 2 courses, may receive 2 courses of IL-2 alone every 8 hours for 5 days,
approximately 2 weeks apart. A separate cohort of 3-9 patients receives modified FPV-gp100.
If no response is observed after 2 courses, IL-2 may be administered as in cohorts 4 and 5.
Patients are followed at 28 days after the second immunization with FPV-gp100.

PROJECTED ACCRUAL: A maximum of 91 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that has failed
standard therapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
More than 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than
100,000/mm3 Hemoglobin greater than 8.0 g/dL No coagulation disorder Hepatic: Bilirubin no
greater than 2.0 mg/dL AST and ALT less than 4 times normal Hepatitis B negative Renal:
Creatinine no greater than 1.6 mg/dL Cardiovascular: No major cardiovascular disease
Pulmonary: No major respiratory disease Other: HIV negative No other major immunologic
illness No eczema No hypersensitivity to eggs No active systemic infection No psoriasis
Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 20 days since prior
therapy No concurrent steroid therapy

Type of Study:

Interventional

Study Design:

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:

CDR0000064960

NCT ID:

NCT00019175

Start Date:

August 1996

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892