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Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission


Phase 2
N/A
18 Years
Not Enrolling
Both
Neuroblastoma

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Trial Information

Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission


OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as
adjuvant therapy in patients with Stage IV neuroblastoma in second remission.

OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal
Antibody 3F8, MOAB 3F8.

PROJECTED ACCRUAL: A maximum of 20 patients will be entered.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or
subsequent complete remission, defined by the complete disappearance of all evidence of
tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow
aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated
by tumor, complete elimination of tumor cells from the marrow compartment must be
demonstrated by histology and immunofluorescence (based on simultaneous bone marrow
aspiration and biopsy samples from at least 4 separate sites)

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy:
Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia
allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3
Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary
dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing
deficit allowed

PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA
titer is less than 1,000 U/mL serum by ELISA

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nai-Kong V. Cheung, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

87-118

NCT ID:

NCT00002458

Start Date:

November 1987

Completion Date:

September 2001

Related Keywords:

  • Neuroblastoma
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021