Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neuroblastoma

Eligibility:

All Genders

1+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells. PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating...

Detailed Description

OBJECTIVES: Primary * Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma. * Determine the acute and late toxicity...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Original diagnosis of neuroblastoma based on 1 of the following criteria:
  • Histopathology
  • Elevated urine catecholamines with typical tumor cells in the bone marrow
  • Refractory or relapsed disease, meeting 1 of the following criteria:
  • Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery)
  • Evidence of disease progression (i.e., any new lesion or an increase in size of \> 25% of a pre-existing lesion) at any time
  • Evaluable disease by MIBG scan within 6 weeks of study entry
  • PATIENT CHARACTERISTICS:
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Bilirubin \< 2 times normal
  • AST/ALT ≤ 10 times normal
  • Creatinine ≤ 2 mg/dL
  • Absolute neutrophil count\* ≥ 750/mm\^3 (transfusion independent)
  • Platelet count\* ≥ 50,000/mm\^3 (20,000/mm\^3 if stem cells are available and platelet transfusion independent)
  • Hemoglobin\* ≥ 10 g/dL (transfusion allowed)
  • No dyspnea at rest
  • No exercise intolerance
  • No oxygen requirement
  • No clinically significant cardiac dysfunction
  • No disease of any major organ system that would preclude study compliance
  • No active infection that meets grade 3 or 4 toxicity criteria NOTE: \*Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 2 weeks since prior antitumor therapy
  • At least 3 months since prior radiotherapy to any of the following fields:
  • Craniospinal
  • Total abdominal
  • Whole lung
  • Total body
  • At least 1 day since prior cytokine therapy (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin-6, or epoetin alfa)
  • Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available
  • No concurrent hemodialysis

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2006

    Estimated Enrollment :

    164 Patients enrolled

    Trial Details

    Trial ID

    NCT00293319

    Start Date

    April 1 2005

    End Date

    March 1 2006

    Last Update

    August 18 2014

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    UCSF Comprehensive Cancer Center

    San Francisco, California, United States, 94115

    2

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109-0942

    3

    Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States, 19104