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A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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).

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Warren Mason, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto

Authority:

United States: Food and Drug Administration

Study ID:

TLN-4601-201

NCT ID:

NCT00730262

Start Date:

August 2008

Completion Date:

June 2010

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme (GBM)
  • Phase II
  • Brain Cancer
  • Glioblastoma

Name

Location

Duke UniversityDurham, North Carolina  27710
Sloan-Kettering Institute for Cancer ResearchNew York, New York  10021