Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
National Cancer Institute (NCI)
OBJECTIVES:
* Determine the response rates of patients with advanced neuroblastoma or other pediatric solid tumors treated with arsenic trioxide.
* Determine the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to type of disease (neuroblastoma with progressive disease vs neuroblastoma with stable refractory disease vs other solid tumor).
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2-3 months for 1 year and then annually thereafter.
Age
0–40
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
* Ewing's family of tumors/primitive neuroectodermal tumor
* Retinoblastoma
* Nephroblastoma
* Osteosarcoma
* Rhabdomyosarcoma
* Desmoplastic small round-cell tumor
* Hepatoblastoma
* Germ cell tumors
* Medulloblastoma
Relapsed from or resistant to prior standard anticancer therapy and/or no known standard therapy available
Measurable disease (e.g., solid mass with definable dimensions) OR
Evaluable disease (e.g., bone marrow involvement or malignant pleural effusion)
PATIENT CHARACTERISTICS:
Age:
40 and under
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Bilirubin no greater than 2.5 times upper limit of normal (ULN)
Renal:
Creatinine no greater than 2.5 times ULN
Cardiovascular:
Absolute QT interval no greater than 460 msec in the presence of adequate potassium and magnesium levels
Other:
No pre-existing neurotoxicity/neuropathy grade 2 or greater
No pre-existing convulsive disorder
No active serious infections uncontrolled by antibiotics
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
More than 3 weeks since prior cytotoxic chemotherapy
No other concurrent cytotoxic chemotherapy
Endocrine therapy:
Not specified
Radiotherapy:
Concurrent radiotherapy allowed provided measurable or evaluable disease exists outside radiation field
