Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma
Intervention: arsenic trioxide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Memorial Sloan Kettering Cancer Center Official(s) and/or principal investigator(s): Brian H. Kushner, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center
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.
Clinical Details
Official title: Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment
Secondary outcome: Toxicity after every course during treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2001
Last updated: April 16, 2013
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