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A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma


OBJECTIVES: I. Determine the toxicity of the human anti-idiotypic monoclonal antibody
vaccine (4B5) plus adjuvant sargramostim (GM-CSF) or alum in patients with stage III or IV
melanoma at high risk for recurrence following surgical resection. II. Determine whether 4B5
is associated with the development of humoral and/or cellular anti-anti-idiotypic immune
response in these patients. III. Determine whether the immune response generated against 4B5
is also directed against the melanoma-associated GD2 antigen in these patients. IV.
Determine whether the 4B5 plus adjuvant GM-CSF or alum can elicit an immune response to GD2
in these patients.

OUTLINE: Patients are assigned sequentially to one of two treatment arms. Arm I: Patients
receive human anti-idiotypic monoclonal antibody vaccine (4B5) in sargramostim (GM-CSF)
subcutaneously (SQ) on days 0, 14, 28, and 42. Patients receive GM-CSF alone SQ at
vaccination site on days 2, 3, and 4 following immunization. Arm II: Patients receive 4B5
plus alum SQ on days 0, 14, 28, and 42. Cohorts of 5 patients receive treatment every 2
weeks for up to 4 courses in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A maximum of 50 patients (25 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Pathologically proven stage III or IV melanoma at high risk for
recurrence following surgical resection The following patients are eligible: Resected
satellite or intransit metastasis with no evidence of residual disease OR Resected
solitary metastatic lesion(s) with no residual disease OR Metastatic melanoma with
measurable disease without noncutaneous lesion(s) greater than 5 cm in diameter OR Stage
III disease not eligible for interferon alfa therapy No active CNS disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: BUN less than 30 mg/dL
Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients
must use effective contraception HIV negative No prior or concurrent active peripheral
neuropathy No immunodeficiency disorder or immunodeficiency state No other prior or
concurrent malignancy, except: Curatively treated basal or squamous cell skin cancer
Carcinoma in situ of the cervix No hypersensitivity to GM-CSF, yeast derived products, or
any study component

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent
immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No
more than 1 prior chemotherapy regimen as adjuvant or for metastatic disease No concurrent
chemotherapy Endocrine therapy: At least 2 weeks since prior glucocorticoids No concurrent
systemic corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least
30 days since other prior investigational drugs No concurrent immunosuppressive therapy
(e.g., cimetidine) No concurrent chronic antihistamine therapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare AEs and SAES in subjects receiving 4B5 plus adjuvant sargramostim (GM-CSF) to alum in patients with stage III or IV melanoma at high risk for recurrence following surgical resection.

Outcome Time Frame:

Baseline to last dose of study drug

Safety Issue:

Yes

Principal Investigator

Donald M. Miller, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

James Graham Brown Cancer Center at University of Louisville

Authority:

United States: Federal Government

Study ID:

CDR0000067424

NCT ID:

NCT00004184

Start Date:

August 1998

Completion Date:

June 2001

Related Keywords:

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

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