N99-02: Melphalan and Buthionine Sulfoximine

Completed · Phase 1

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00005835

Run by

New Approaches to Neuroblastoma Therapy Consortium

People needed

31

Starts

2001-08-01

Expected to finish

2016-04-01

Last updated by the study team

2023-04-10

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients have relapsed neuroblastoma and must have exhausted all other options for treatment before they can be considered for treatment on this study.
• Relapsed patients who are greater than 6 months since having a stem cell transplant can enter on this study.
• Patients must have stem cells collected and stored before starting treatment.
• Patients must have a double lumen central venous line in place.
• Patients must have adequate kidney and liver function measured by blood tests and test of renal function (creatinine clearance or glomerular filtration rate (GFR)).
• Patients must have normal heart and lung function measured by lack of physical evidence or clinical history of difficulties breathing and tests of cardiac function (Echocardiogram or MUGA evaluation).
• Patients must have an essentially normal neurological exam.
• Patients must have one entire kidney that has not had any radiation at treatment doses. (Xrays and scans are ok).
• Patients must have recovered from the effects of any prior treatment for their tumor.

You may not qualify if…

• They have had any radiation therapy to the brain.
• They have known history of or current tumor found in the brain or surrounding tissues.
• They have a history of seizures.
• They have a history of changes in a test of kidney function with antibiotic use in the 6 months immediately before entering on this study.

Where it is running

• Childrens Hospital Los Angeles — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Chicago Comer Children's Hospital — Chicago, Illinois, United States
• Childrens Hospital Boston, Dana-Farber Cancer Institute. — Boston, Massachusetts, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Cook Children's Medical Center - Fort Worth — Fort Worth, Texas, United States
• Children's Hospital and Regional Medical Center - Seattle — Seattle, Washington, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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