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



Status:Completed
Conditions:Ovarian Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 40
Updated:4/21/2016
Start Date:March 2001
End Date:May 2009

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Phase II Study of Arsenic Trioxide in Neuroblastoma and Other Pediatric 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.

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.

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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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mi
from
New York, NY
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