Multiple Therapies in Treating Patients With Advanced Neuroblastoma

NCT00040872 | Completed Phase 2

• 4 other identifiers: 00-065P30CA008748MSKCC-00065NCI-G02-2083
• Study Type: interventional
• Target: N/A
• 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 peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Combining different types of therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy, monoclonal antibody therapy, surgery, peripheral stem cell transplantation, radiation therapy, and biological therapy in treating patients who have advanced neuroblastoma.

Conditions

Neuroblastoma

Keywords

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

Interventions

filgrastim BIOLOGICAL

monoclonal antibody 3F8 BIOLOGICAL

sargramostim BIOLOGICAL

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

isotretinoin DRUG

thiotepa DRUG

topotecan hydrochloride DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

conventional surgery PROCEDURE

drug resistance inhibition treatment PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

syngeneic bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma by 1 of the following: * Histologic confirmation, including immunohistochemical, ultrastructural, or cytogenetic studies * Elevated urinary catecholamines plus tumor cells/clumps in the bone marrow * Poor-risk disease, defined by 1 of the following: * Stage IV disease * Unresectable primary disease plus N-myc amplification * Infant (under age 1) with stage IV disease plus N-myc amplification * Previously treated disease allowed PATIENT CHARACTERISTICS: Age: * 50 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No prior allergy to mouse proteins * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior murine antibodies allowed if human anti-mouse antibody (HAMA) titer is less than 1,000 ELISA units/mL Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics

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
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; humanized 3F8 anti-GD2 monoclonal antibody; sargramostim; Carboplatin; Cisplatin; Cyclophosphamide; Doxorubicin; Etoposide; Isotretinoin; Thiotepa; Topotecan; Vincristine; Peripheral Blood Stem Cell Transplantation; Radiotherapy

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; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Nai-Kong V. Cheung, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

US (1)