N99-01: Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma

NCT00005978 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000067966P01CA081403N99-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 15

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given before stem cell transplant and radiation therapy in treating patients with neuroblastoma that has not responded to previous treatments.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; regional neuroblastoma; disseminated neuroblastoma; stage 4S neuroblastoma; recurrent neuroblastoma; localized unresectable neuroblastoma

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

etoposide DRUG

melphalan DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

iobenguane I 131 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma as evidenced by one of the following: * Histological confirmation * Demonstrates clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites * High-risk refractory or residual disease * Poorly responding disease, meeting 1 of the following criteria: * Stable disease or partial response after at least 12 weeks of induction therapy * Bone marrow containing greater than 100 tumor cells per 100,000 normal cells after 12 weeks of induction therapy * Progressive disease during or after therapy * At least 1 prior positive iodine I 131 metaiodobenzylguanidine (131 I-MIBG) scan since diagnosis and meets disease status criteria PATIENT CHARACTERISTICS: Age: * 1 to 21 (1 to 20 at diagnosis) Performance status: * ECOG 0-2 Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count at least 500/mm\^3 * Platelet count at least 20,000/mm\^3 (transfusion allowed) * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: * Bilirubin normal * AST/ALT no greater than 3 times normal * No active hepatitis (for HIV-positive patients only) Renal: * Glomerular filtration rate or creatinine clearance at least 60 mL/min * Creatinine less than 1.5 times normal for age Cardiovascular: * Ejection fraction at least 55% OR * Fractional shortening at least 30% Pulmonary: * No dyspnea at rest or exercise intolerance * No requirement for supplemental oxygen * No active pneumonia (for HIV-positive patients only) Other: * No disease of any major organ system that would preclude study participation * No other active health problems (for HIV-positive patients only) * No active infections requiring intravenous antivirals, antibiotics, or antifungals * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic therapy and recovered Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No more than 100 mg/m\^2 total dose of prior melphalan Endocrine therapy: * Not specified Radiotherapy: * No prior total body, whole abdominal, or whole liver irradiation * No prior therapy with 131 I-MIBG * At least 2 weeks since prior radiotherapy (6 months for prior radiotherapy to craniospinal or whole lung fields or greater than 50% of bone marrow space) and recovered Surgery: * Prior surgical resection allowed * Recovered from prior surgery Other: * No prior myeloablative therapy * Prior submyeloablative therapy with peripheral blood stem cell support allowed * No concurrent antiretrovirals for HIV-positive patients * Concurrent prolonged antifungal allowed if culture and biopsy negative in suspected residual radiographic lesions * No medications that may preclude uptake of 131 I-MIBG for 1 week prior and 2 weeks after administration of study drugs * No concurrent hemodialysis

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

Sponsors & Collaborators

• New Approaches to Neuroblastoma Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (15)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Lucile Packard Children's Hospital at Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus

Atlanta, Georgia, 30322, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Publications (1)

• Matthay KK, Tan JC, Villablanca JG, Yanik GA, Veatch J, Franc B, Twomey E, Horn B, Reynolds CP, Groshen S, Seeger RC, Maris JM. Phase I dose escalation of iodine-131-metaiodobenzylguanidine with myeloablative chemotherapy and autologous stem-cell transplantation in refractory neuroblastoma: a new approaches to Neuroblastoma Therapy Consortium Study. J Clin Oncol. 2006 Jan 20;24(3):500-6. doi: 10.1200/JCO.2005.03.6400.

  PMID: 16421427 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Carboplatin; Etoposide; Melphalan; Peripheral Blood Stem Cell Transplantation; 3-Iodobenzylguanidine; 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; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Guanidines; Amidines; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Iodinated

Study Officials

• Katherine K. Matthay, MD

  Children's Hospital Los Angeles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: December 23, 2003
• Study Start: May 1, 2000
• Primary Completion: December 1, 2004
• Last Updated: October 15, 2010

Record last verified: 2009-05

Locations

US (15)