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Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase 1/Phase 2
Not Enrolling
Acute Lymphoblastic Leukemia

Thank you

Trial Information

Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia


- Determine the maximum tolerated dose (MTD) of liposomal vincristine given with
dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia

- Determine the efficacy of liposomal vincristine given with dexamethasone in these

Inclusion Criteria:

- Previously treated, relapsed or refractory ALL (including lymphoblastic lymphoma and
Burkitt's subtypes) with measurable disease.

- 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:

- Active serious infection not controlled by oral or intravenous antibiotics.

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Deborah Thomas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center, Department of Hematology/Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

July 2002

Completion Date:

August 2006

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Emory University Atlanta, Georgia  30322
University of Chicago Medical Center Chicago, Illinois  60637
University of Texas M.D. Anderson Cancer Center Houston, Texas  77030