N2000-01: Double Infusion of Iodine I 131 Metaiodobenzylguanidine Followed by Autologous Stem Cell Transplantation

NCT00083135 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000363631P01CA081403N2000-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief Summary

RATIONALE: Giving iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) may kill neuroblastoma cells by delivering radiation directly to the tumor. A stem cell transplant using the patient's stem cells may be able to replace blood-forming cells destroyed by radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of a double infusion of \^131I-MIBG followed by autologous stem cell transplantation in treating patients with refractory neuroblastoma.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma

Interventions

filgrastim BIOLOGICAL

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

iobenguane I 131 RADIATION

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of neuroblastoma * Confirmed by at least 1 of the following methods: * Histology * Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites * High-risk disease * Poor response to induction therapy OR relapse defined by any of the following: * No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy * More than 100 tumor cells per 10\^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy * Progressive disease at any time during or after therapy * Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed * Must have positive iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks * Must meet the following criteria for minimum number of autologous stem cells: * Unpurged peripheral blood stem cells (PBSC) * Minimum of 1,500,000/mm\^3 CD34-positive cells/kg * Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology * PBSC purged with immunomagnetic beads * Minimum of 1,000,000/mm\^3 viable CD34-positive cells/kg * Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology * CD34-positive selected PBSC products are not allowed * Patients who had PBSC collected previously with no immunocytological testing available may use those products provided bone marrow is tumor free by bilateral bone marrow aspirate AND biopsy for morphology is performed within 4 weeks before PBSC collection * Patients with no tumor involvement in bone marrow at diagnosis and PBSC collection before any disease progression do not require documentation of negative bone marrow morphology PATIENT CHARACTERISTICS: Age * 1 to 30 Performance status * ECOG 0-2 Life expectancy * Less than 1 year Hematopoietic * Absolute neutrophil count ≥ 500/mm\^3 * Platelet count ≥ 50,000/mm\^3 (without transfusion) * Hemoglobin ≥ 8 g/dL (transfusion allowed) Hepatic * AST and ALT ≤ 5 times normal * Bilirubin \< 2 times normal Renal * Creatinine ≤ 1.5 mg/dL * Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m\^2 Cardiovascular * Ejection fraction ≥ 55% by echocardiogram or MUGA OR * Fractional shortening ≥ 30% OR above lower limit of normal by echocardiogram Pulmonary * Normal lung function * No dyspnea at rest * No exercise intolerance * No oxygen requirement Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to cooperate physically and psychologically with radiation isolation * No disease of any major organ system that would preclude study participation * No active infection requiring antivirals, antibiotics, or antifungals * No weight that would require exceeding a maximum total allowable dose of \^131I-MIBG PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior biologic or other non-myelosuppressive therapy Chemotherapy * See Disease Characteristics * At least 2 weeks since prior chemotherapy * More than 3 months since prior myeloablative therapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 6 months since prior craniospinal, total abdominal, or whole lung radiotherapy * At least 2 weeks since prior radiotherapy to any site * No prior total body irradiation * No prior radiotherapy to \> 25% of bone marrow * No prior \^131I-MIBG Surgery * Not specified Other * Recovered from all prior therapy * Concurrent antifungal therapy allowed provided culture and biopsy are negative in suspected radiographic lesions * Prior re-induction therapy for recurrent tumor allowed * No concurrent antiretroviral therapy for HIV-positive patients * No concurrent hemodialysis

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

Sponsors & Collaborators

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

Study Sites (7)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, 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

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Publications (2)

• Matthay KK, Quach A, Huberty J, Franc BL, Hawkins RA, Jackson H, Groshen S, Shusterman S, Yanik G, Veatch J, Brophy P, Villablanca JG, Maris JM. Iodine-131--metaiodobenzylguanidine double infusion with autologous stem-cell rescue for neuroblastoma: a new approaches to neuroblastoma therapy phase I study. J Clin Oncol. 2009 Mar 1;27(7):1020-5. doi: 10.1200/JCO.2007.15.7628. Epub 2009 Jan 26.

  PMID: 19171714 RESULT

• Taggart DR, Han MM, Quach A, Groshen S, Ye W, Villablanca JG, Jackson HA, Mari Aparici C, Carlson D, Maris J, Hawkins R, Matthay KK. Comparison of iodine-123 metaiodobenzylguanidine (MIBG) scan and [18F]fluorodeoxyglucose positron emission tomography to evaluate response after iodine-131 MIBG therapy for relapsed neuroblastoma. J Clin Oncol. 2009 Nov 10;27(32):5343-9. doi: 10.1200/JCO.2008.20.5732. Epub 2009 Oct 5.

  PMID: 19805691 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Peripheral Blood Stem Cell Transplantation; 3-Iodobenzylguanidine

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; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Katherine K. Matthay, MD

  University of California, San Francisco

  STUDY CHAIR

• Gregory Yanik, MD

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

• John M. Maris, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: March 1, 2004
• Primary Completion: February 1, 2006
• Last Updated: April 14, 2026

Record last verified: 2009-05

Locations

US (7)