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

Phase 2

Terminated

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: TLN-4601

• Registration Number: NCT00730262
• Lead Sponsor: Thallion Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-29
• Last Update Posted: 2009-12-30
• Primary Completion: 2010-04
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	TLN-4601	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (8)

Duke University; 🇺🇸 Durham, North Carolina, United States

The Pencer Brain Tumor Center, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada

Hôpital Notre-Dame du CHUM; 🇨🇦 Montreal, Quebec, Canada

Sloan-Kettering Institute for Cancer Research; 🇺🇸 New York, New York, United States

Ottawa Health Research Institute; 🇨🇦 Ottawa, Ontario, Canada

L'Hotel-Dieu de Quebec; 🇨🇦 Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada