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NCT00024258 · REGISTRY CONDITION SEARCH

Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2015-11-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
40 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. 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.
    intervention Names
    1. Drug: arsenic trioxide
    label
    Arsenic Trioxide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arsenic Trioxide
    name
    arsenic trioxide
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
22
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment
    time Frame
    1 year
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice