Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006092 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis |
Study Start Date: | October 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course.
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Acute lymphoblastic leukemia
Blastic phase chronic myelogenous leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 |
Study Chair: | Thomas P. Loughran, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000068097, MCC-12395, NCI-1230 |
Study First Received: | August 3, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006092 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Arsenic trioxide Leukemia, Myeloid Recurrence |
Leukemia Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Chronic Myelogenous Leukemia Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Arsenic trioxide Leukemia, Myeloid |
Pharmacologic Actions Translocation, Genetic Leukemia Lymphatic Diseases Neoplasms Pathologic Processes Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chromosome Aberrations Bone Marrow Diseases Lymphoproliferative Disorders |