NCT00730262

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
2 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 30, 2009

Status Verified

December 1, 2009

Enrollment Period

1.7 years

First QC Date

August 6, 2008

Last Update Submit

December 29, 2009

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme (GBM)Phase IIBrain Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (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)

Study Arms (1)

Single-Arm

EXPERIMENTAL
Drug: TLN-4601

Interventions

TLN-4601DRUG

14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period

Also known as: Formerly ECO-4601
Single-Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sloan-Kettering Institute for Cancer Research

New York, New York, United States

Location

Duke University

Durham, North Carolina, United States

Location

Ottawa Health Research Institute

Ottawa, Ontario, Canada

Location

The Pencer Brain Tumor Center, Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Hôpital Notre-Dame du CHUM

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

L'Hotel-Dieu de Quebec

Québec, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

MeSH Terms

Conditions

GlioblastomaBrain Neoplasms

Interventions

diazepinomicin

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Warren Mason, MD

    The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2010

Study Completion

June 1, 2010

Last Updated

December 30, 2009

Record last verified: 2009-12

Locations

CA(6)US(2)