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Status:

COMPLETED

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

Lead Sponsor:

Children's Hospital Los Angeles

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neuroblastoma

Eligibility:

All Genders

1-30 years

Phase:

PHASE1

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 m...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated red marrow radiation dose delivered and associated toxic effects of escalating activity of iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) fo...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00083135

    Start Date

    March 1 2004

    Last Update

    October 15 2010

    Active Locations (7)

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

    Page 1 of 2 (7 locations)

    1

    Children's Hospital Los Angeles

    Los Angeles, California, United States, 90027-0700

    2

    UCSF Comprehensive Cancer Center

    San Francisco, California, United States, 94143

    3

    Indiana University Cancer Center

    Indianapolis, Indiana, United States, 46202-5289

    4

    Children's Hospital Boston

    Boston, Massachusetts, United States, 02115