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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Talon Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00144963
First received: September 1, 2005
Last updated: May 11, 2012
Last verified: December 2011
History of Changes

September 1, 2005
May 11, 2012
July 2002
August 2006   (final data collection date for primary outcome measure)
MTD of VSLI [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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.
Not Provided
Complete list of historical versions of study NCT00144963 on ClinicalTrials.gov Archive Site
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Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia

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).

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.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • Drug: 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).
    Other Name: Marqibo
  • Drug: Dexamethasone
    Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
Experimental: VSLI
Vincristine Sulfate Liposomes Injection (VSLI)
Interventions:
  • Drug: Vincristine Sulfate Liposomes Injection
  • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2006
August 2006   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00144963
VSLI-06-ALL
No
Talon Therapeutics, Inc
Talon Therapeutics, Inc
Not Provided
Principal Investigator: Deborah Thomas, MD MD Anderson Cancer Center, Department of Hematology/Oncology
Principal Investigator: Wendy Stock, MD University of Chicago
Principal Investigator: Leonard Heffner, MD Emory University
Talon Therapeutics, Inc
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP