Phase 2 N=22 Treatment

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

Brain and Central Nervous System Tumors · Childhood Germ Cell Tumor · Extragonadal Germ Cell Tumor · Kidney Cancer · Liver Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00024258 ↗

Enrolled (actual)

Serious AEs

54.6%

Results posted

Nov 2015

Primary outcome: Primary: Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment — 16; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: arsenic trioxide (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment	16; 5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00024258). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.