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Sponsored by: |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00008697 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of arsenic trioxide in treating patients with refractory or recurrent acute promyelocytic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: arsenic trioxide |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Trial of Infusional Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia |
Estimated Enrollment: | 32 |
Study Start Date: | May 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive arsenic trioxide IV over 2 hours daily for 28 days followed by a 14 day rest period. Patients may receive up to 3 courses of treatment.
Dose escalation continues in cohorts of 3-6 patients until the maximum tolerated dose (MTD) or minimum effective dose (MED) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. The MED is defined as the dose at which 4 of 6 patients achieve a complete cytogenetic or molecular response. After the MTD or MED is determined, an additional 20 patients are enrolled at this dose level.
Patients are followed monthly for 6 months and every three months for an additional 1.5 years.
PROJECTED ACCRUAL: Approximately 32 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Missouri | |
Siteman Cancer Center | |
Saint Louis, Missouri, United States, 63110 |
Study Chair: | John F. DiPersio, MD, PhD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000066617, WU-98-0185, NCI-V98-1466 |
Study First Received: | January 13, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00008697 |
Health Authority: | United States: Federal Government |
recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia adult acute promyelocytic leukemia (M3) childhood acute promyelocytic leukemia (M3) |
Leukemia Acute promyelocytic leukemia Acute myelogenous leukemia Leukemia, Promyelocytic, Acute Arsenic trioxide |
Acute myeloid leukemia, adult Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Recurrence |
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |