CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
arsenic trioxidedrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid)
  • ✓Relapsed from or resistant to prior standard anticancer therapy, or no known standard therapy available
  • ✓Measurable disease (solid mass with definable dimensions) OR evaluable disease (bone marrow involvement or malignant pleural effusion)
  • ✓Age 40 years and under
Key exclusion· 5
  • ✕Pre-existing neurotoxicity or neuropathy grade 2 or greater
  • ✕Pre-existing convulsive disorder
  • ✕Active serious infections uncontrolled by antibiotics
  • ✕Concurrent cytotoxic chemotherapy other than the study drug

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00024258
NCT00024258Phase 2Completed
CompareCT.gov

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

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Nov 25, 2015

In Brief

A Phase 2 clinical trial evaluating arsenic trioxide for Brain and Central Nervous System Tumors and 8 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2001
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 23.4 years ago

Interventions

arsenic trioxidedrug