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

Phase 2

Completed

• Conditions: Extragonadal Germ Cell Tumor; Kidney Cancer; Ovarian Cancer; Retinoblastoma; Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Liver Cancer; Neuroblastoma; Sarcoma
• Interventions: Drug: arsenic trioxide

• Registration Number: NCT00024258
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2001-09-13
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2015-10
• Results First Submitted: 2015-10-22
• Results First Submitted QC: 2015-10-22
• Last Update Submitted: 2015-10-22
• Results First Posted: 2015-11-25
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arsenic Trioxide	arsenic trioxide	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States