- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006092
Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
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
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.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.
- Determine the duration of hematologic response and overall survival of these patients when treated with this regimen.
- Determine the pattern of clinical adverse experience in these patients when treated with this regimen.
- Determine the pharmacokinetic profile of this regimen in these patients.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Acute lymphoblastic leukemia
- Philadelphia chromosome (Bcr-abl) positive
- Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation
Blastic phase chronic myelogenous leukemia
- Philadelphia chromosome (Bcr-abl) positive
- Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate
- Must not be eligible for bone marrow transplant
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 times upper limit of normal (ULN)
- AST/ALT no greater than 2 times ULN
Renal:
- Creatinine no greater than 2.0 times ULN
- Creatinine clearance greater than 70 mL/min
Cardiovascular:
- No uncontrolled angina
- No New York Heart Association class III or IV heart disease
- No second degree heart block without pacemaker
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after study
- HIV negative
- No uncontrolled infection or other serious concurrent illness
- No peripheral neuropathy
- No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR
- No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected
- Electrolyte imbalances must be corrected prior to study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
- At least 28 days since prior chemotherapy
- At least 24 hours since prior hydroxyurea
- No prior arsenic trioxide
- No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 28 days since prior radiotherapy
- No concurrent radiotherapy including for palliation
Surgery:
- Not specified
Other:
- At least 14 days since prior imatinib mesylate
- No other concurrent investigational agents
- No concurrent amphotericin B
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arsenic Trioxide Treatment
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.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Rate of Response (ORR)
Time Frame: 2.5 years
|
Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide.
|
2.5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Thomas P. Loughran, MD, H. Lee Moffitt Cancer Center and Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-12395
- NCI-1230 (Other Identifier: NCI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia
-
Massachusetts General HospitalCelgene CorporationTerminatedAcute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic LeukemiaUnited States
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...RecruitingRefractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, ChildhoodChina
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationActive, not recruitingAcute Myelogenous LeukemiaUnited States
-
Massachusetts General HospitalCompleted
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States
-
National Cancer Institute (NCI)TerminatedAdult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloblastic Leukemia Without Maturation... and other conditionsUnited States
-
Hybrigenics CorporationUnknownAcute Myelogenous LeukemiaUnited States, France
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
Clinical Trials on Arsenic Trioxide
-
Ruijin HospitalRecruitingRefractory Solid TumorsChina
-
CTI BioPharmaTerminatedMultiple Myeloma and Plasma Cell NeoplasmUnited States
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
National Cancer Institute (NCI)CompletedLymphoma | LeukemiaUnited States, Canada, Australia
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Leukemia | Multiple Myeloma and Plasma Cell NeoplasmUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI)CompletedTesticular Germ Cell Tumor | Extragonadal Germ Cell TumorUnited States
-
Washington University School of MedicineNational Cancer Institute (NCI)Completed
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Northwestern UniversityNational Cancer Institute (NCI)TerminatedLymphomaUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)Completed