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

Sponsor
Thallion Pharmaceuticals (Industry)
Overall Status
Terminated
CT.gov ID
NCT00730262
Collaborator
(none)
40
Enrollment
8
Locations
1
Arm
22
Duration (Months)
5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
Study Start Date :
Aug 1, 2008
Anticipated Primary Completion Date :
Apr 1, 2010
Anticipated Study Completion Date :
Jun 1, 2010

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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). [6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)]

    Secondary Outcome Measures

    1. To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM [Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sloan-Kettering Institute for Cancer Research New York New York United States
    2 Duke University Durham North Carolina United States
    3 Ottawa Health Research Institute Ottawa Ontario Canada
    4 The Pencer Brain Tumor Center, Princess Margaret Hospital Toronto Ontario Canada
    5 Hôpital Notre-Dame du CHUM Montreal Quebec Canada
    6 Royal Victoria Hospital Montreal Quebec Canada
    7 Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec Canada
    8 L'Hotel-Dieu de Quebec Quebec Canada

    Sponsors and Collaborators

    • Thallion Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00730262
    Other Study ID Numbers:
    • TLN-4601-201
    First Posted:
    Aug 8, 2008
    Last Update Posted:
    Dec 30, 2009
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    Glioblastoma Multiforme (GBM)
    Phase II
    Brain Cancer
    Additional relevant MeSH terms:
    Glioblastoma

    Study Results

    No Results Posted as of Dec 30, 2009