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Phase 2
18 Years
Not Enrolling
Recurrent Glioblastoma Multiforme

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Trial Information

Inclusion Criteria

Inclusion criteria:

The patients must fulfill all the following criteria:

- Previous histologically-confirmed diagnosis of primary GBM (glioma grade 4 at time of
first diagnosis).

- Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after
previous resection (surgical or biopsy) and radiation therapy.

- Medically capable of undergoing the planned surgical gross total resection and the
catheter placement.

- Age ≥ 18.

- Karnofsky Performance Status of ≥ 70%.

- Life expectancy of ≥ 3 months.

- Patients must already be taking or begin taking corticosteroids at a stable dose of 4
mg every 6 hours for at least 72 hours prior to catheter placement.

- Patients must be capable of taking, or already taking, anticonvulsant medication.

- Patients must have read, signed, and dated an informed consent according to ICH-GCP,
the local regulatory requirement and the rules followed at each institution.

Exclusion Criteria:

Patients fulfilling any of the following criteria should not be enrolled in the study:

- Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the
infusion. Patients who have received more than two chemotherapy regimens (single
therapy or combination therapy) are ineligible.

- Any form of brain radiation within 10 weeks of the start of the infusion.

- Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal
radiotherapy, unless the recurrence/progression is histologically confirmed
(fine-needle biopsy).

- Prior intracavitary biologic response modifiers or monoclonal antibodies.

- Uncontrolled seizures.

- Bilateral or multifocal tumors.

- Evidence of cerebral uncal herniation.

- Midline brain shift on MRI scan of > 0.5 cm prior to resection; patients with
subfalcine herniation may be enrolled.

- Tumors involving the brainstem or cerebellum.

- Diffuse subependymal or CSF disease.

- Women who are pregnant or breast feeding. All women of child-bearing potential
should be excluded unless they have a negative pregnancy test and are using adequate
contraceptive measures or are surgically sterile. Post-menopausal women must be
amenorrhoeic for at least 12 months to be considered of non-childbearing.

- Fertile males not practicing adequate contraception and whose female partners are not
using adequate contraceptive protection.

- Prior or concurrent investigational treatment within 30 days of study entry.

- Active infection requiring treatment or having an unexplained febrile illness.

- Systemic diseases or other conditions which may be associated with unacceptable
anesthetic/operative risk and/or which would not allow safe completion of this study

- Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell
carcinoma or patients who have been disease free for at least 5 years are eligible).

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

% patients alive

Outcome Time Frame:

28 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2003

Completion Date:

July 2006

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • gross total resection
  • Brain Neoplasms
  • Glioblastoma