Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
NCT ID: NCT00144963
Last Updated: 2019-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2002-07-31
2006-08-31
Brief Summary
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Detailed Description
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* Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
* Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VSLI
Vincristine Sulfate Liposomes Injection (VSLI)
Vincristine Sulfate Liposomes Injection
Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
Dexamethasone
Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
Interventions
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Vincristine Sulfate Liposomes Injection
Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
Dexamethasone
Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Performance status ≤3 (ECOG).
* All ages are eligible. Those aged 12 years or older may be counted towards the MTD in the Phase I portion of the trial. Pediatric patients are eligible, but must be treated at a dose level previously tested in an adult (one full course).
* Adequate liver function (bilirubin ≤2 x upper limit normal), and renal function (creatinine ≤2 x upper limit normal).
* Negative pregnancy test in females of childbearing potential.
* Patients with prior history of stem cell transplant are eligible if they meet all other eligibility requirements.
Exclusion Criteria
* Treatment with any investigational agents or chemotherapy agents in the last 21 days before study entry, unless full recovery from side effects has occurred or the patient has rapidly progressive disease judged to be life threatening by the Investigator.
* Concurrent treatment with other anti-cancer agents other than dexamethasone.
* Known CNS leukemia or lymphoma requiring intrathecal or craniospinal radiation therapy or with CNS neuropathy limiting evaluation of study drug. Patients with controlled CNS disease (no progression signs or symptoms at the time of study entry) may be eligible after approval by the Principal Investigator. Lumbar puncture not required in asymptomatic patients.
* Prior history of Grade 3 or 4 sensory or motor neuropathy related to chemotherapeutic treatment, or persistent Grade 2 or greater active neuropathy.
* History of active neurologic disorders unrelated to chemotherapy (including familial neurologic diseases and acquired demyelinating disorders).
* Prior history of hypersensitivity reactions to vincristine or any of the other components of VSLI.
* Pregnant and/or lactating women; or fertile men or women not willing to use contraception.
ALL
No
Sponsors
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Acrotech Biopharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Deborah Thomas, MD
Role: PRINCIPAL_INVESTIGATOR
MD Anderson Cancer Center, Department of Hematology/Oncology
Wendy Stock, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Leonard Heffner, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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VSLI-06-ALL
Identifier Type: -
Identifier Source: org_study_id
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