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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Kidney Cancer; Liver Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma

Intervention: arsenic trioxide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Brian H. Kushner, MD, Study Chair, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

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

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

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

Secondary outcome: Toxicity after every course during treatment

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

Minimum age: N/A. Maximum age: 40 Years. Gender(s): Both.

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

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2001
Last updated: April 16, 2013

Page last updated: August 23, 2015

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