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

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TLN-4601
Sponsored by
Thallion Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma Multiforme (GBM), Phase II, Brain Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sloan-Kettering Institute for Cancer Research
  • Duke University
  • Ottawa Health Research Institute
  • The Pencer Brain Tumor Center, Princess Margaret Hospital
  • Hôpital Notre-Dame du CHUM
  • Royal Victoria Hospital
  • Centre Hospitalier Universitaire de Sherbrooke
  • L'Hotel-Dieu de Quebec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM

Full Information

First Posted
August 6, 2008
Last Updated
December 29, 2009
Sponsor
Thallion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00730262
Brief Title
Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
Official Title
A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Thallion Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma Multiforme (GBM), Phase II, Brain Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TLN-4601
Other Intervention Name(s)
Formerly ECO-4601
Intervention Description
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren Mason, MD
Organizational Affiliation
The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sloan-Kettering Institute for Cancer Research
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Ottawa Health Research Institute
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
The Pencer Brain Tumor Center, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
L'Hotel-Dieu de Quebec
City
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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