N2004-06: Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma

Completed · Phase 1

Conditions studied: Neuroblastoma

In brief

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine (MIGB), may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as irinotecan and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving iodine I 131 MIGB together with irinotecan and vincristine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 MIGB when given together with irinotecan and vincristine in treating young patients with resistant or relapsed high-risk neuroblastoma.

Key facts

Study ID

NCT00509353

Run by

New Approaches to Neuroblastoma Therapy Consortium

People needed

26

Starts

2007-01-01

Expected to finish

2012-05-01

Last updated by the study team

2026-04-14

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a diagnosis of neuroblastoma by histologic verification and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
• Must have high-risk neuroblastoma AND meets at least one of the following criteria:
• Recurrent or progressive disease at any time
• Biopsy not required, even if there is partial response to intervening therapy
• Refractory disease (i.e., less than a partial response to frontline therapy, including a minimum of 4 courses of chemotherapy)
• Biopsy not required
• If the patient has not had previous myeloablative therapy, preference will be given to NANT-2001-02 (iodine I 131 metaiodobenzylguanidine [\^131I-MIBG] + CEM)
• Persistent disease after at least a partial response to frontline therapy (i.e., patient still has residual disease by MIBG scan, CT/MRI scan, or bone marrow)
• Biopsy required (bone marrow biopsy included) of at least one residual site demonstrating viable neuroblastoma
• If the patient has not had previous myeloablative therapy, preference will be given to NANT-2001-02 (\^131I-MIBG + CEM)
• Must have evidence of MIBG uptake into tumor at ≥ 1 site within 4 weeks prior to study entry and subsequent to any intervening therapy
• Must have autologous hematopoietic stem cell product available and it must be free of tumor cell contamination (0 tumor cells /1,000,000 nucleated cells), cryopreserved, and available for re-infusion after \^131I-MIBG treatment, if immunocytology has been performed on the stem cell product
• If immunocytology has not been performed on the stem cell product, then bilateral bone marrow aspirates and biopsies must have been negative by morphology within 4 weeks before or after the stem cell collection
• If the patient had no bone marrow disease documented at diagnosis or at any time prior to peripheral blood stem cell (PBSC) harvest then the criteria for bilateral bone marrow aspirates/biopsies is waived
• The minimum dose is as follows:
• Purged PBSC 2.0 x 10\^6 viable CD34+ cells/kg
• Immuno-magnetically purged cells are permitted
• Unpurged PBSC 2 x 10\^6 CD34+ cells/kg (minimum is same for PBSC from identical twin)
• Cells from identical twins are permitted
• Other allogeneic cells are not allowed
• CD34+ selected cells are not permitted
• PATIENT CHARACTERISTICS:
• Inclusion criteria:
• Lansky or Karnofsky performance status ≥ 50%
• Life expectancy ≥ 6 weeks

You may not qualify if…

• Pregnancy or breast feeding
• Dyspnea at rest, exercise intolerance, pleural effusion, or oxygen requirement
• Disease of any major organ system that would compromise the patient's ability to withstand therapy
• Documented allergy to third generation cephalosporins
• Active diarrhea (defined as ≥ grade 2 per CTCAE v3)
• Active or uncontrolled infection, including C. difficile
• Patients on prolonged antifungal therapy are eligible if suspected radiographic lesions are culture and biopsy negative and patient meets other organ function criteria
• Patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation
• Patient weight that would require exceeding a maximum total allowable dose of \^131I-MIBG (per institutional guidelines)
• Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
• PRIOR CONCURRENT THERAPY:
• Inclusion criteria:
• Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before study entry
• At least 3 weeks since prior myelosuppressive or biologic therapy
• At least 2 weeks since prior radiation therapy
• Radiation therapy should not be given to the only site of measurable or evaluable disease
• At least 3 months since prior large field radiation therapy (i.e., craniospinal radiation therapy, total lung radiation therapy, or radiation therapy to > 50% of marrow space)
• At least 3 months since prior autologous stem cell transplantation
• Must meet adequate bone marrow function postmyeloablative therapy
• At least 7 days since prior cytokines or hematopoietic growth factors
• Prior irinotecan hydrochloride and vincristine therapy allowed provided the patient recovered to adequate bone marrow function as specified in the protocol
• Exclusion criteria:
• Prior \^131I-MIBG
• Prior external beam radiation therapy to the liver or kidneys
• Prior allogeneic stem cell transplantation

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus — Atlanta, Georgia, United States
• University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital at University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center - Fort Worth — Fort Worth, Texas, United States
• Children's Hospital and Regional Medical Center - Seattle — Seattle, Washington, United States
• University of Wisconsin Paul P. Carbone Comprehensive Cancer Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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