Brief Title
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Official Title
Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment
Condition
Brain and Central Nervous System Tumors
Intervention
arsenic trioxide
Study Arms / Comparison Groups
Arsenic Trioxide
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
22
Start Date
March 2001
Completion Date
May 2009
Primary Completion Date
May 2009
Eligibility Criteria
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
Gender
All
Ages
N/A - 40 Years
Accepts Healthy Volunteers
No
Contacts
Brian H. Kushner, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00024258
Organization ID
01-042
Secondary IDs
P30CA008748
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Brian H. Kushner, MD, Study Chair, Memorial Sloan Kettering Cancer Center
Verification Date
October 2015