Arsenic Trioxide in Treating Patients With Advanced Solid Tumors

June 20, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase I Study of Arsenic Trioxide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

August 1, 2000

Study Completion (Actual)

August 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 23, 2004

First Posted (Estimate)

June 24, 2004

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-046
  • CDR0000066713 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G98-1479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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