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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00730262
First received: August 6, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Glioblastoma Multiforme
Drug: TLN-4601
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Thallion Pharmaceuticals:

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). [ Time Frame: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Formerly ECO-4601

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730262

Locations
United States, New York
Sloan-Kettering Institute for Cancer Research
New York, New York, United States
United States, North Carolina
Duke University
Durham, North Carolina, United States
Canada, Ontario
Ottawa Health Research Institute
Ottawa, Ontario, Canada
The Pencer Brain Tumor Center, Princess Margaret Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Canada
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
  More Information

No publications provided

Responsible Party: Didier Reymond, MD / Vice-President Medical and Clinical Affairs, Thallion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00730262     History of Changes
Other Study ID Numbers: TLN-4601-201
Study First Received: August 6, 2008
Last Updated: December 29, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Thallion Pharmaceuticals:
Glioblastoma Multiforme (GBM)
Phase II
Brain Cancer

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on October 23, 2014