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

NCT00144963 | Completed Phase 1 Results

• 1 other identifier: VSLI-06-ALL
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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).

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• MTD of VSLI

  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.

  6 weeks

Study Arms (1)

VSLI

EXPERIMENTAL

Vincristine Sulfate Liposomes Injection (VSLI)

Drug: Vincristine Sulfate Liposomes Injection; Drug: Dexamethasone

Interventions

Vincristine Sulfate Liposomes Injection DRUG

Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).

Also known as: Marqibo

VSLI

Dexamethasone DRUG

Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).

VSLI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Vincristine; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: VP, Regulatory Affairs
• Organization: Talon Therapeutics

ttarlow@talontx.com

650-228-5066

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: July 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: December 12, 2019
• Results First Posted: January 18, 2012

Record last verified: 2019-12

Locations

US (3)