Know Cancer

forgot password

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

Phase 2
40 Years
Not Enrolling
Brain and Central Nervous System Tumors, Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Kidney Cancer, Liver Cancer, Neuroblastoma, Ovarian Cancer, Retinoblastoma, Sarcoma

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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)



- 40 and under

Performance status:

- Not specified

Life expectancy:

- Not specified


- Not specified


- Bilirubin no greater than 2.5 times upper limit of normal (ULN)


- Creatinine no greater than 2.5 times ULN


- Absolute QT interval no greater than 460 msec in the presence of adequate potassium
and magnesium levels


- 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


Biologic therapy:

- Not specified


- More than 3 weeks since prior cytotoxic chemotherapy

- No other concurrent cytotoxic chemotherapy

Endocrine therapy:

- Not specified


- Concurrent radiotherapy allowed provided measurable or evaluable disease exists
outside radiation field


- Not specified


- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate after every 3 courses during treatment and then every 2-3 months for 1 year after completion of treatment

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Brian H. Kushner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2001

Completion Date:

May 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Kidney Cancer
  • Liver Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Retinoblastoma
  • Sarcoma
  • 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
  • childhood malignant testicular germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood extragonadal germ cell tumor
  • recurrent childhood malignant germ cell tumor
  • 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



Memorial Sloan-Kettering Cancer Center New York, New York  10021