Phase II Trial of the Effects of Interferon Alfa-2b on the Immunogenicity of a Polyvalent Melanoma Antigen Vaccine in Patients With Stage III Malignant Melanoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Phase II Trial of the Effects of Interferon Alfa-2b on the Immunogenicity of a Polyvalent Melanoma Antigen Vaccine in Patients With Stage III Malignant Melanoma


OBJECTIVES: I. Determine the effect of interferon alfa-2b on the potentiation of
antimelanoma antibodies and cellular immune responses induced by immunization to a
polyvalent melanoma vaccine and interleukin-2 in patients with stage III malignant melanoma.
II. Determine the optimal dose of interferon that will maximally stimulate these responses
in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are randomized into a vaccine treated control
arm or to receive one of two doses of interferon alfa-2b plus vaccine. All patients receive
polyvalent melanoma vaccine incorporated into interleukin-2 liposomes. The vaccine is
administered intradermally every 2 weeks for 8 weeks, monthly for 3 months, and then every 3
months for a total of 2 years or until disease progression. Patients assigned to arms II or
III also receive interferon alfa-2b subcutaneously, at one of two doses, three times a week
for 2 years. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven, surgically resected stage III melanoma
Clinically positive nodes AND/OR At least 2 histologically positive nodes HLA-A2, A3, A11,
or A26 positive Intact cellular immunity as evidenced by at least 5 mm reaction at 48
hours to at least 1 of the following recall antigens: PPD Mumps Candida Streptokinase
streptodornase OR able to be sensitized to dinitrochlorobenzene

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: At
least 12 months Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than
100,000/mm3 Hematocrit greater than 30% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no
greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2
times ULN Prothrombin time normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No
significant cardiovascular disease No uncontrolled hypertension No congestive heart
failure No uncontrolled cardiac arrhythmia No active angina pectoris No myocardial
infarction in the past 12 months Pulmonary: Other: No second malignancy except carcinoma
in situ of the cervix or basal or squamous cell skin cancer No autoimmune disease HIV
negative No significant medical illness that would preclude compliance At least 4 weeks
since prior serious infection requiring antibiotics Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior melanoma vaccine No prior
immunotherapy No other concurrent immunotherapy Chemotherapy: No prior chemotherapy No
concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior
glucocorticosteroids for nonmalignant purposes No concurrent steroids Radiotherapy: No
concurrent radiotherapy Surgery: At least 4 weeks (but no more than 12 weeks) since prior
major surgery Other: No concurrent immunosuppressive drugs

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jean-Claude Bystryn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000067323

NCT ID:

NCT00004104

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • Melanoma

Name

Location
Kaplan Cancer Center New York, New York  10016