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Multi-national, Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma, Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week


Phase 2
18 Years
75 Years
Not Enrolling
Both
Glioblastoma, Anaplastic Astrocytoma

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Trial Information

Multi-national, Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma, Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week


The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and
standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic
astrocytoma [AA], WHO grade III; or glioblastoma [GBM], WHO grade IV). AP 12009 is a
phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming
growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant
progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis
and escape from immunosurveillance. It has been shown that in a number of tumor types the
degree of TGF-beta production strongly correlates with tumor grade and stage. In patients
with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage,
clinical prognosis and the immunodeficient state of the patients.


Inclusion Criteria:



- Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma
(anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)

- Supratentorial localization

- No more than two chemotherapy regimens including radiochemotherapy since primary
diagnosis

- Eligible for either TMZ or PCV treatment

- Recovery from acute toxicity caused by any previous therapy

- Adequate organ functions

- KPS at least 70%

Exclusion Criteria:

- Tumor surgery within 2 weeks prior to study entry

- Radiation therapy within 8 weeks prior to study entry

- Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)

- No more than 3 mg/day dexamethasone (or equivalent) at baseline

- Prior TGF-beta targeted therapy or tumor vaccination

- Baseline MRI shows mass effect

- Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal
infection

- Significant psychiatric disorders/legal incapacity or a limited legal capacity

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate of two AP 12009 dose groups and control group assessed by the evaluation of tumor size on brain MRI scans

Safety Issue:

No

Principal Investigator

Ulrich Bogdahn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Regensburg, Dept. of Neurology, Germany

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

AP 12009-G004

NCT ID:

NCT00431561

Start Date:

April 2003

Completion Date:

March 2009

Related Keywords:

  • Glioblastoma
  • Anaplastic Astrocytoma
  • Glioblastoma
  • Anaplastic astrocytoma
  • Antisense
  • Cancer
  • Transforming growth factor beta2 (TGF-beta2)
  • Targeted therapy
  • Immunotherapy
  • Brain tumor
  • Central nervous system (CNS)
  • Convection-enhanced delivery (CED) / microperfusion
  • Locoregional application
  • Astrocytoma
  • Glioblastoma

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