Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
Phase 2
Completed
- Conditions
- Glioblastoma Multiforme
- Interventions
- Drug: TP-38
- Registration Number
- NCT00104091
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Immunotoxin therapy may be effective in treating malignant glioma. Immunotoxins can locate tumor cells and kill them without harming normal cells.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
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 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 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 protocol.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 TP-38 40 mL of TP-38 at a 100 nanograms/mL concentration
- Primary Outcome Measures
Name Time Method Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity 26 weeks
- Secondary Outcome Measures
Name Time Method Efficacy parameters including time to progression, safety, and survival 26 weeks