Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating children who have advanced neuroblastoma or other solid tumors.

Study summary:

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.


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 Surgery: - Not specified Other: - No other concurrent investigational agents



Primary Contact:

Study Chair
Brian H. Kushner, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.