Arsenic Trioxide in Treating Patients With Advanced Solid Tumors

Study Description

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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.

Condition or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific	Drug: arsenic trioxide	Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. III. Evaluate evidence of clinical responsiveness to this treatment regimen.

OUTLINE: This is a dose escalation, open label study. Patients are stratified by age (pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. Patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. Patients are followed for at least 1 month after treatment.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	Phase I Study of Arsenic Trioxide
Study Start Date :	August 1998
Actual Primary Completion Date :	August 2000
Actual Study Completion Date :	August 2000

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor Relapsed from or resistant to at least 1 course of standard anticancer therapy AND/OR Lack of standard therapy that is known to be beneficial in the underlying disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 2.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 months following study No active serious infections that are not controlled by antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Steven Soignet, MD	Memorial Sloan Kettering Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00003630 History of Changes
Other Study ID Numbers:	98-046; CDR0000066713 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-G98-1479
First Posted:	June 24, 2004
Last Update Posted:	June 24, 2013
Last Verified:	June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:

unspecified childhood solid tumor, protocol specific; unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms; Arsenic trioxide; Antineoplastic Agents