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Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma


Phase 2
16 Years
N/A
Not Enrolling
Both
Stage IV Melanoma, Recurrent Melanoma

Thank you

Trial Information

Phase II Study of DNA Encoding the gp100 Antigen Alone or in Combination With Interleukin-2 in Patients With Recurrent Metastatic Melanoma


OBJECTIVES: I. Determine the clinical response of patients receiving DNA gp100 antigen
alone or in combination with interleukin-2 for recurrent metastatic melanoma.

II. Identify the immunologic response in these patients prior to and after these
treatments.

III. Determine the toxicity of these treatments in these patients.

PROTOCOL OUTLINE: Patients are accrued for the first three cohorts and the study proceeds to
the final two cohorts if responses are observed.

Cohort I: Patients receive gp100 antigen intramuscularly (IM) into each of 2 proximal
extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort II:
Patients receive gp100 antigen intradermally (ID) at 5 sites on each of 2 proximal
extremities once every 4 weeks for up to 4 doses. (Closed as of December, 1999) Cohort III:
Patients receive gp100 antigen IM into each of 2 proximal extremities once every 4 weeks for
up to 4 doses. If patients do not exhibit immunologic response or dose-limiting toxicity,
they may receive a higher dose of gp100 antigen on subsequent courses.

Cohort IV: If cohorts I, II, or III do not produce an immune response and do not experience
dose-limiting toxicity, patients receive a higher dose of gp100 antigen IM into each of 2
proximal extremities every 4 weeks for up to 4 doses.

Cohort V: Patients receive gp100 antigen IM or ID at the dose found to produce immunization
once every 4 weeks for up to 4 doses. Patients also receive interleukin-2 IV over 15
minutes every 8 hours for 5 days (15 doses), beginning within 24 hours after gp100 antigen.

Patients with minor, mixed, or partial response or stable disease may receive additional
courses of treatment following 3-4 weeks of rest. Patients receive a maximum of 12 courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL:

A maximum of 65 patients will be accrued for this study within 1 year.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of metastatic melanoma that has failed standard
therapy Measurable disease --Prior/Concurrent Therapy-- Biologic therapy: At least 3 weeks
since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy
Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid
therapy Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Prior surgery
allowed --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0 or 1 Life
expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at
least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL
ALT/AST less than 2 times normal Hepatitis B surface antigen negative Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major
respiratory disease Other: Not pregnant Negative pregnancy test Fertile patients must use
effective contraception No active systemic infections No autoimmune disease No primary or
secondary immunodeficiency HIV negative

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000066215

NCT ID:

NCT00019448

Start Date:

September 1998

Completion Date:

March 2007

Related Keywords:

  • Stage IV Melanoma
  • Recurrent Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • melanoma
  • recurrent melanoma
  • skin tumor
  • solid tumor
  • stage IV melanoma
  • stage, melanoma
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892