Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme

December 29, 2009 updated by: Thallion Pharmaceuticals

A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme

The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • L'Hôtel-Dieu de Québec
    • Ontario
      • Ottawa, Ontario, Canada
        • Ottawa Health Research Institute
      • Toronto, Ontario, Canada
        • The Pencer Brain Tumor Center, Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada
        • Hopital Notre-Dame du CHUM
      • Sherbrooke, Quebec, Canada
        • Centre hospitalier universitaire de Sherbrooke
  • United States
    • New York
      • New York, New York, United States
        • Sloan-Kettering Institute for Cancer Research
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed Glioblastoma Multiforme (GBM)
  • Prior treatment with radiation and one first line systemic therapy (including temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination therapies), followed by measurable and unequivocal evidence of tumor progression or recurrence
  • Age ≥ 18 years
  • ECOG ≤ 2

  • Normal organ and marrow function as defined below:

    • leukocytes ≥3 x 109/L
    • absolute neutrophil count ≥1.5 x 109/L
    • platelets ≥100 x 109/L
    • hemoglobin ≥90 g/L
    • total bilirubin ≤2.5 X institutional upper limit of normal
    • AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
    • creatinine ≤1.0 X institutional upper limit of normal

Exclusion Criteria:

  • Patients with a life expectancy < 12 weeks
  • Patients with a documented history of HIV, active hepatitis B or C infections
  • Female patients who are pregnant or lactating
  • Patients in whom a proper central line (Portacath-like device) cannot be established
  • Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or polysorbate 80
  • Patients with uncontrolled hypotension
  • Patients with concomitant therapy of therapeutic coumadin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Arm
Drug: TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
Other Names:
  • Formerly ECO-4601

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1).
Time Frame: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM
Time Frame: Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thallion Pharmaceuticals

Investigators

  • Principal Investigator: Warren Mason, MD, The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

December 30, 2009

Last Update Submitted That Met QC Criteria

December 29, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLN-4601-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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