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| Sponsored by: |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00008697 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| 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) |
|
Acute Myeloid Leukemia, Childhood Leukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute |
Arsenic trioxide Leukemia, Myeloid Leukemia, Myeloid, Acute Acute Promyelocytic Leukemia Recurrence |
|
Leukemia Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Leukemia, Promyelocytic, Acute Arsenic trioxide Leukemia, Myeloid Leukemia, Myeloid, Acute Pharmacologic Actions |
