Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors - Full Text View

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

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity after every course during treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2001
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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.

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Brian H. Kushner, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Brian H. Kushner )
Study ID Numbers:	CDR0000068906, MSKCC-01042, CTI-1059, NCI-G01-2014
Study First Received:	September 13, 2001
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00024258 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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:

Retinal Neoplasms
Liver Diseases
Neuroectodermal Tumors, Primitive
Antineoplastic Agents
Gonadal Disorders
Neoplasms, Nerve Tissue
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Retinoblastoma
Urologic Neoplasms
Neuroblastoma
Genital Diseases, Female
Liver Neoplasms
Neoplasms, Connective and Soft Tissue

Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Kidney Diseases
Retinal Diseases
Nervous System Neoplasms
Endocrine Gland Neoplasms
Ovarian Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Eye Neoplasms
Eye Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on March 18, 2010