Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00024258
First received: September 13, 2001
Last updated: April 16, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors |
Resource links provided by NLM:
MedlinePlus related topics:
Arsenic
Cancer
Kidney Cancer
Liver Cancer
Neuroblastoma
Ovarian Cancer
Soft Tissue Sarcoma
Wilms' Tumor
U.S. FDA Resources
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity after every course during treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | March 2001 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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. |
Drug: arsenic trioxide |
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.
Eligibility| Ages Eligible for Study: | up to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024258
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Study Chair: | Brian H. Kushner, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00024258 History of Changes |
| Other Study ID Numbers: | 01-042, P30CA008748, MSKCC-01042, CTI-1059, NCI-G01-2014 |
| Study First Received: | September 13, 2001 |
| Last Updated: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013