Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy

Phase 1

Terminated

• Conditions: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
• Interventions: Drug: arsenic trioxide; Drug: tretinoin

• Registration Number: NCT00006220
• Lead Sponsor: Washington University School of Medicine

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells.
...

Detailed Description

This is a dose escalation and efficacy study of arsenic trioxide. In the efficacy study, patients are stratified according to diagnosis (acute myelogenous leukemia vs acute lymphocytic leukemia vs myelodysplastic syndrome vs multiple myeloma vs non-Hodgkin's lymphoma and Hodgkin's disease). Phase I: Patients receive arsenic trioxide IV over 2 hours daily for...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 1999-06
• Study First Submitted: 2000-09-11
• Primary Completion: 2000-11
• Study Completion: 2002-02
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase I	arsenic trioxide	Starting dose of arsenic trioxide of 0.15 mg/kg/day
Treatment Failure	tretinoin	Arsenic trioxide and tretinoin
Phase II	arsenic trioxide	MTD of arsenic trioxide
Treatment Failure	arsenic trioxide	Arsenic trioxide and tretinoin

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)	28 days
Likelihood of complete (CR) or partial (PR) response following therapy	6 months

Secondary Outcome Measures

Name	Time	Method
Explore the pharmacokinetics of arsenic trioxide alone and in combination with ATRA
Evaluate acute and chronic toxicities of arsenic trioxide alone and in combination with ATRA.
Determine the effects of arsenic trioxide alone and combined with ATRA on bcl-2, pml, and class I antigen expression and on apoptosis. Determine the effects of arsenic trioxide on T and B cell number and function		Only when patients are circulating tumor cells.

Trial Locations

Locations (1)

Washington University Barnard Cancer Center; 🇺🇸 Saint Louis, Missouri, United States