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N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA


Phase 2
1 Year
N/A
Not Enrolling
Both
Neuroblastoma

Thank you

Trial Information

N7: EVALUATION OF MAXIMAL CHEMOTHERAPY DOSE INTENSITY PLUS MONOCLONAL ANTIBODY 3F8 IN THE TREATMENT OF NEUROBLASTOMA


OBJECTIVES: I. Improve the complete remission rate and progression-free survival and reduce
the relapse rate of patients with poor-risk neuroblastoma using intensive multimodality
therapy: cyclophosphamide/doxorubicin/vincristine and cisplatin/etoposide, external-beam
radiotherapy, and surgery (when feasible), followed by radioimmunotherapy with iodine I 131
labeled monoclonal antibody 3F8 followed by autologous bone marrow transplant and
immunotherapy with unlabeled 3F8. II. Identify biologic and clinical prognostic factors that
may guide future modifications in treatment approaches for this malignancy.

OUTLINE: Patients are stratified by prior therapy (yes vs no). Patients undergo surgery
either at diagnosis or after at least 4 courses of chemotherapy, then possibly again after
completion of chemotherapy. Patients receive cyclophosphamide IV over 6 hours on days 1-2,
and doxorubicin IV and vincristine IV over 72 hours on days 1-3 for courses 1, 2, 4, and 6.
Cisplatin IV over 1 hour on days 1-4 and vincristine IV over 2 hours on days 1-3 are
administered as courses 3, 5, and 7. Courses are administered every 16-21 days. Autologous
bone marrow is collected after 3 courses of chemotherapy providing marrow is negative for
tumor cells. Patients undergo radiotherapy after the completion of chemotherapy.
Radiotherapy is administered twice a day for 7 days. Patients then receive iodine I 131
labeled monoclonal antibody 3F8 (MOAB 3F8) on day -5 and again on days 1-5. Autologous bone
marrow is reinfused on day 5 and filgrastim (G-CSF) is administered IV or subcutaneously
beginning day 6. Patients who do not develop HAMA or an allergy to mouse proteins receive
unlabeled MOAB 3F8 IV over 1.5 hours, 5 days a week for 2 weeks. Treatment repeats every 1-2
months for up to 4 courses. Patients are followed every month for 2 years, every 3 months
for 1 year, then annually thereafter.

PROJECTED ACCRUAL: Up to 45 newly diagnosed patients will be accrued for this study within 5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Neuroblastoma diagnosed in accordance with the International
Neuroblastoma Staging system: Histologic confirmation at MSKCC OR Elevated urinary
catecholamines plus tumor cells/clumps in bone marrow Stage IV or Stage II/III with more
than 10 copies of N-myc proto-oncogene per tumor cell

PATIENT CHARACTERISTICS: See General Eligibility Criteria

PRIOR CONCURRENT THERAPY: Prior therapy allowed -Patient Characteristics-- Age: Over 1
year at diagnosis Performance status: Not specified Hematopoietic: Absolute neutrophil
count at least 500/mm3 (except for cases of bone marrow infiltration by tumor) Platelet
count at least 100,000/mm3 (except for cases of bone marrow infiltration by tumor)
Hepatic: Not specified Renal: Not specified Other: No history of allergy to mouse proteins
Human antimouse antibodies (HAMA) less than 1,000 U/ml (with prior exposure to murine
antibodies)

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:

CDR0000064084

NCT ID:

NCT00002634

Start Date:

February 1995

Completion Date:

Related Keywords:

  • Neuroblastoma
  • localized resectable neuroblastoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • recurrent neuroblastoma
  • localized unresectable neuroblastoma
  • Neuroblastoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021