Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy
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|ClinicalTrials.gov Identifier: NCT00006220|
Recruitment Status : Terminated (Study drug became commercially available.)
First Posted : May 20, 2004
Last Update Posted : February 6, 2013
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.
PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes||Drug: arsenic trioxide Drug: tretinoin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Arsenic Trioxide Alone or With ATRA (Vesanoid) for Resistant Hematologic Malignancy|
|Study Start Date :||June 1999|
|Primary Completion Date :||November 2000|
|Study Completion Date :||February 2002|
Experimental: Phase I
Starting dose of arsenic trioxide of 0.15 mg/kg/day
|Drug: arsenic trioxide|
Experimental: Phase II
MTD of arsenic trioxide
|Drug: arsenic trioxide|
Experimental: Treatment Failure
Arsenic trioxide and tretinoin
|Drug: arsenic trioxide Drug: tretinoin|
- Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
- Likelihood of complete (CR) or partial (PR) response following therapy [ Time Frame: 6 months ]
- 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 functionOnly when patients are circulating tumor cells.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006220
|United States, Missouri|
|Washington University Barnard Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|Study Chair:||Randy A. Brown, MD||Washington University Siteman Cancer Center|