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Completed

NCT Number: NCT00024258

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Adnexal Diseases Central Nervous System Neoplasms Childhood Germ Cell Tumor Congenital, Hereditary, and Neonatal Diseases and Abnormalities Desmoplastic Small Round Cell Tumor Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Extragonadal Germ Cell Tumor Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioma Gonadal Disorders Hepatoblastoma Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Male Urogenital Diseases Medulloblastoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Syndromes, Hereditary Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Osteosarcoma Ovarian Cancer Ovarian Diseases Ovarian Germ Cell Cancer Ovarian Neoplasms Retinal Diseases Retinal Neoplasms Retinoblastoma Sarcoma Teratoma Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Wilms Tumor

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arsenic trioxide

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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