Clinical trial NCT00024258: Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors
Official title: Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Kidney Cancer
Liver Cancer
Neuroblastoma
Ovarian Cancer
Retinoblastoma
Sarcoma
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 22
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian H. Kushner, MD
role: STUDY_CHAIR
References: