Clinical trial · Interventional

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

Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors

NCT00024258CI-TRIAL-00019938completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Childhood Germ Cell Tumor	Childhood Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Extragonadal Germ Cell Tumor	Extragonadal Germ Cell Tumor	ONTOLOGY_EXACT	0.98
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Liver Cancer	Malignant Liver Neoplasm	CURATED_EXACT	0.92
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Retinoblastoma	Retinoblastoma	ONTOLOGY_EXACT	0.98
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
arsenic trioxide	Drug	Arsenic Trioxide	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
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.
interventionNames
1. Drug: arsenic trioxide

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
timeFrame
1 year

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 40 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment