Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

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Brief Title

Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Official Title

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

Brief Summary

      The purpose of this study is to find the highest safe dose and to assess the anti-tumor
      effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory
      acute lymphoblastic leukemia (ALL).
    

Detailed Description

      OBJECTIVES:

        -  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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

MTD of VSLI


Condition

Acute Lymphoblastic Leukemia

Intervention

Vincristine Sulfate Liposomes Injection

Study Arms / Comparison Groups

 VSLI
Description:  Vincristine Sulfate Liposomes Injection (VSLI)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

July 2002

Completion Date

August 2006

Primary Completion Date

August 2006

Eligibility Criteria

        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 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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Deborah Thomas, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00144963

Organization ID

VSLI-06-ALL


Responsible Party

Sponsor

Study Sponsor

Acrotech Biopharma LLC


Study Sponsor

Deborah Thomas, MD, Principal Investigator, MD Anderson Cancer Center, Department of Hematology/Oncology


Verification Date

December 2019