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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024258 |
Purpose
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.
| Condition | Intervention | Phase |
|
Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Retinoblastoma Sarcoma |
Drug: arsenic trioxide |
Phase II |
| Genetics Home Reference related topics: | retinoblastoma |
| MedlinePlus related topics: | Arsenic Cancer Kidney Cancer Liver Cancer Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma Wilms' Tumor |
| Drug Information available for: | Arsenic trioxide |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2001 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 45-120 patients (15-40 per stratum) will be accrued for this study.
Eligibility
| Ages Eligible for Study: | up to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed neuroblastoma or other pediatric solid tumor (nonmyeloid and nonlymphoid) including the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |||||
| Memorial Sloan-Kettering Cancer Center | |||||
| New York, New York, United States, 10021 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Brian H. Kushner ) |
| Study ID Numbers: | CDR0000068906, MSKCC-01042, CTI-1059, NCI-G01-2014 |
| First Received: | September 13, 2001 |
| Last Updated: | October 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024258 |
| Health Authority: | United States: Federal Government |
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