Clinical trial NCT00730262: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma Multiforme (GBM)
Phase II
Brain Cancer
Lead sponsor: Thallion Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Secondary outcomes:
measure: To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM
timeFrame: Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: Sloan-Kettering Institute for Cancer Research
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute
state: Ontario
city: Toronto
country: Canada
facility: The Pencer Brain Tumor Center, Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: L'Hotel-Dieu de Quebec
Study officials:
affiliation: The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
name: Warren Mason, MD
role: PRINCIPAL_INVESTIGATOR
References: