CompletedPhase 2

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

United States50 participantsStarted 2005-09

Plain-language 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, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.

Who can participate

Age range1 Year – 29 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion

Timeframe: Response assessed 60 days post stem cell infusion

Trial details

NCT IDNCT00253435

SponsorNew Approaches to Neuroblastoma Therapy Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2014-08-25