Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) (NSC-326321) and Autologous Stem Cell Support For Recurrent High Risk Neuroblastoma (NCI 68).
This study uses a new combination of two anti-cancer drugs, Buthionine Sulfoximine (BSO) given with melphalan followed by autologous stem cell support to try to get rid of any remaining cancer cells.
Melphalan is a traditional anti cancer agent that is effective in neuroblastoma.
BSO is a new drug that has been shown in the laboratory to increase the number of neuroblastoma cancer cells that are killed when BSO is used together with melphlan.
It is hoped that giving BSO together with melphalan will kill more neuroblastoma cancer cells than melphalan would by itself.
Why is this study being done:
To find the highest dose of melphalan that can be given with BSO without causing severe side effects.
To measure the blood levels of melphalan and BSO during treatment.
To determine if the neuroblastoma tumor gets smaller after getting this treatment.
Watch a video describing this clinical trial
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Criteria which need to be met to participate in this study:
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.
Patients cannot participate in this study 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.
N99-02 video
