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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2001 |
| Primary Completion Date: | May 2009 (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 | |
| Study Chair: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Brian H. Kushner, Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00024258 History of Changes |
| Other Study ID Numbers: | CDR0000068906, MSKCC-01042, CTI-1059, NCI-G01-2014 |
| Study First Received: | September 13, 2001 |
| Last Updated: | July 22, 2009 |
| Health Authority: | United States: Federal Government |
|
metastatic osteosarcoma recurrent childhood rhabdomyosarcoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma stage III childhood liver cancer stage IV childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma stage III Wilms tumor stage IV Wilms tumor stage V Wilms tumor recurrent Wilms tumor and other childhood kidney tumors intraocular retinoblastoma |
extraocular retinoblastoma recurrent retinoblastoma recurrent osteosarcoma childhood germ cell tumor metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma localized unresectable neuroblastoma previously untreated childhood rhabdomyosarcoma childhood desmoplastic small round cell tumor untreated childhood medulloblastoma recurrent childhood medulloblastoma previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood teratoma |
|
Carcinoma, Renal Cell Kidney Neoplasms Liver Neoplasms Nervous System Neoplasms Neuroblastoma Ovarian Neoplasms Retinoblastoma Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Digestive System Neoplasms Digestive System Diseases Liver Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Nerve Tissue Endocrine Gland Neoplasms |
