Chemotherapy, Radiation Therapy, Immunotherapy, and Bone Marrow Transplantation in Treating Patients With Neuroblastoma

NCT00002634 | Completed Phase 2

• 4 other identifiers: 94-011CDR0000064084MSKCC-FDR001041NCI-V95-0622
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, radiation therapy, immunotherapy, and bone marrow transplantation in treating patients with neuroblastoma.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; regional neuroblastoma; disseminated neuroblastoma; recurrent neuroblastoma; localized unresectable neuroblastoma

Interventions

filgrastim BIOLOGICAL

monoclonal antibody 3F8 BIOLOGICAL

cisplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

mesna DRUG

perfosfamide DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

in vitro-treated bone marrow transplantation PROCEDURE

low-LET cobalt-60 gamma ray therapy RADIATION

low-LET photon therapy RADIATION

radioisotope therapy RADIATION

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Cheung NV, Kushner BH, LaQuaglia MP, et al.: Anti-Gd2 monoclonal antibody (MOAB) 3F8-targeted therapy and dose intensity for children (1 yr of age) with stage 4 neuroblastoma (NB): key variables in sequential protocols at Memorial Sloan Kettering Cancer Center (MSKCC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-2305, 2000.

  BACKGROUND

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; humanized 3F8 anti-GD2 monoclonal antibody; Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Mesna; perfosfamide; Vincristine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Nai-Kong V. Cheung, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 23, 2004
• Study Start: February 1, 1995
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

US (1)