Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors (NCT00024258) | Clinical Trial Compass
CompletedPhase 2
Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
United States22 participantsStarted 2001-03
Plain-language 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.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 therap…
What they're measuring
1
Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment