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Neuroblastoma

Melphalan and Buthionine Sulfoximine Followed by Bone Marrow Transplant for Children With Resistant or Recurrent Neuroblastoma (NANT 9902)
Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) with Autologous Stem Cell Support for Resistant/Recurrent High-Risk Neuroblastoma (IND #69,112)
Status Conditions Phase Study ID
Recruiting Neuroblastoma Phase I NANT 9902
NCT00005835
Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma.


Investigator
Julie Park, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of high-risk neuroblastoma confirmed by histology and/or tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • Meets 1 of the following response status criteria:

    • Current or previous progressive disease
    • Mixed or no response following completion of minimum of 4 courses of induction therapy
  • Meets 1 of the following criteria:

    • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Metaiodobenzylguanidine (MIBG) scan with uptake at a minimum of one site
    • Bone marrow disease documented by standard morphology of bilateral bone marrow aspirate and biopsy specimens

      • Documentation by positive immunocytology is not sufficient
    • Biopsy of a lesion seen on bone scan that is non-avid for MIBG and that demonstrates viable neuroblastoma
  • Meets 1 of the following criteria for harvested autologous stem cells:

    • Availability of at least 1.5 x 10^6 CD34-positive unpurged autologous peripheral blood stem cells per kg of body weight*
    • Availability of at least 1.0 x 10^6 viable CD34-positive purged autologous peripheral blood stem cells per kg of body weight*

      • A backup source of stem cells is required if there are < 1.5 x 10^6 CD34-positive viable cells/kg available for infusion
    • Availability of at least 1 x 10^8 purged autologous mononuclear bone marrow cells per kg of body weight* NOTE: *Product to be infused must have 0 tumor cells by immunocytology
  • No history of intraparenchymal brain lesion
  • No concurrent intraparenchymal brain lesion or meningeal/parameningeal soft tissue mass extending directly into the cranial cavity by CT, MRI, or metaiodobenzylguanidine scan

PATIENT CHARACTERISTICS:

Age:

  • Over 9 months to 30 years

Performance status:

  • ECOG or Zubrod 0-1

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count at least 500/mm^3
  • Platelet count at least 20,000/mm^3 (transfusion allowed)
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin normal
  • AST and ALT no greater than 2.5 times normal
  • No active hepatitis if HIV positive

Renal:

  • Glomerular filtration rate or creatinine clearance ≥ 100 mL/min
  • Creatinine ≤ 1.5 times normal

Cardiovascular:

  • Ejection fraction at least 55% by echocardiogram or MUGA scan OR
  • Fractional shortening at least 30% by echocardiogram

Pulmonary:

  • No dyspnea at rest or exercise intolerance
  • No active pneumonia if HIV positive

Neurologic:

  • No grade 1 or greater neurological function abnormality except grade 1 irritability, headache, dizziness, insomnia, or somnolence (if due to narcotic analgesics)
  • No history of seizures

Other:

  • No other active health problems if HIV positive
  • No concurrent neoplastic or nonneoplastic disease of any major organ system that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • At least 3 weeks since prior biologic therapy and recovered

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Recovered from prior radiotherapy
  • Prior diagnostic radiotherapy allowed
  • More than 6 months since prior radiotherapy to mantle and Y ports
  • More than 3 months since prior therapeutic metaiodobenzylguanidine (^131I-MIBG) and no more than 20 mCl/kg total dose received
  • At least 2 weeks since prior radiotherapy to all other sites
  • More than 6 months since prior radiotherapy to kidneys, liver, heart, skull, or face

    • No more than 25% of the liver can have received > 1800 cGy
    • No more than 20% of one of the kidneys can have received > 1200 cGy
    • No more than a 10 cc volume of the brain can have received > 1000 cGy
  • No prior total body irradiation
  • No prior total cranial or craniospinal radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from any prior therapy
  • At least 7 days since prior antibiotics, antifungals, or antivirals
  • No acetaminophen or cephalosporin antibiotics for at least 7 days before, during, and until at least 2 weeks after buthionine sulfoximine infusion
  • No prophylactic antimicrobials (i.e., nystatin or sulfamethoxazole/trimethoprim) for at least 7 days before, during, and until at least 7 days after buthionine sulfoximine infusion
  • No concurrent antiretroviral medications for HIV-positive patients
Last Updated
April 13, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.