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Status:

COMPLETED

N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

Lead Sponsor:

Children's Hospital Los Angeles

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neuroblastoma

Eligibility:

All Genders

1-29 years

Phase:

PHASE2

Brief Summary

RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etop...

Detailed Description

OBJECTIVES: Primary * Determine the response rate in patients with relapsed or refractory neuroblastoma treated with iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) and combination chemotherapy c...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of relapsed or refractory neuroblastoma
  • Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • High-risk neuroblastoma must meet one of the following:
  • Progressive disease prior to or after completion of induction therapy
  • Mixed response or no response after completion of 4 courses of induction therapy
  • Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials
  • Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions)
  • PATIENT CHARACTERISTICS:
  • Performance status
  • Lansky 60-100% OR
  • Karnofsky 60-100%
  • Life expectancy
  • At least 2 months
  • Hematopoietic
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 750/mm\^3
  • Platelet count ≥ 50,000/mm\^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (\> 20,000/mm\^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed)
  • Hepatic
  • Bilirubin \< 1.3 mg/dL
  • SGOT and SGPT \< 5 times normal
  • Hepatitis B surface antigen negative
  • Hepatitis C negative
  • Renal
  • Glomerular filtration rate or creatinine clearance ≥ 60 ml/min
  • Creatinine ≤ 1.5 times normal for age as follows:
  • 8 mg/dL (for patients ≤ 5 years of age)
  • 0 mg/dL (for patients 6 to 10 years of age)
  • 2 mg/dL (for patients 11 to 15 years of age)
  • 5 mg/dL (for patients \> 15 years of age)
  • Cardiovascular
  • Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR
  • Fractional shortening ≥ 27% by echocardiogram
  • Pulmonary
  • Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation \> 93% on room air
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No disease of any major organ system that would preclude study compliance
  • No concurrent hemodialysis
  • No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions)
  • Patient weight within limits to receive ≤ maximum total allowable dose of \^131I-MIBG
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior myeloablative transplantation
  • Prior submyeloablative transplantation allowed at discretion of principal investigator
  • More than 3 weeks since prior biologic therapy
  • Chemotherapy
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • No prior melphalan therapy with a total dose of \> 100 mg/m\^2
  • Radiotherapy
  • See Disease Characteristics
  • At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy)
  • No prior total body irradiation
  • No prior iodine I 131 MIBG (\^131I-MIBG)
  • No prior total abdominal or whole liver radiotherapy
  • No prior local radiotherapy, including any of the following:
  • 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed)
  • 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver
  • Other
  • Recovered from all prior therapy
  • No medications with a potential interference of \^131I-MIBG uptake 1 week before and 2 weeks after completion of \^131I-MIBG

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2013

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00253435

    Start Date

    September 1 2005

    End Date

    December 1 2013

    Last Update

    April 10 2023

    Active Locations (15)

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

    Page 1 of 4 (15 locations)

    1

    Childrens Hospital Los Angeles

    Los Angeles, California, United States, 90027-0700

    2

    Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, United States, 94304

    3

    UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, United States, 94143

    4

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

    Atlanta, Georgia, United States, 30322