N99-02: Melphalan and Buthionine Sulfoximine

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Approaches to Neuroblastoma Therapy Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Buthionine Sulfoximine; Melphalan

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.