A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection
The patients must fulfill all the following criteria:
- Previous histologically-confirmed diagnosis of primary GBM (glioblastoma multiforme,
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
- 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.
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
- 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
amenorrheic for at least 12 months to be considered 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).