Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors
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ClinicalTrials.gov Identifier: NCT00071539 |
Recruitment Status
:
Completed
First Posted
: October 29, 2003
Last Update Posted
: January 20, 2012
|
Sponsor:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
- Study Details
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Brief Summary:
Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Glioblastoma Multiforme | Drug: TP-38 Drug: TP38 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | January 2006 |
Actual Study Completion Date : | July 2006 |
Arm | Intervention/treatment |
---|---|
Experimental: TP38 50 ng/mL |
Drug: TP-38
Recombinant chimeric protein
Other Name: immunotoxin
|
Experimental: TP38 100 ng/mL |
Drug: TP38
recombinant chimeric protein
Other Name: immunotoxin
|
Primary Outcome Measures
:
- Survival [ Time Frame: 28 weeks ]% patients alive
Secondary Outcome Measures
:
- Time to progression (TTP) [ Time Frame: 28 weeks ]An independent review committee will review MRI scans and will be blinded to the dose each patient received.
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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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).
No Contacts or Locations Provided
Responsible Party: | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier: | NCT00071539 History of Changes |
Other Study ID Numbers: |
IXR-102-22-188 |
First Posted: | October 29, 2003 Key Record Dates |
Last Update Posted: | January 20, 2012 |
Last Verified: | January 2012 |
Keywords provided by Teva Pharmaceutical Industries:
gross total resection |
Additional relevant MeSH terms:
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Immunotoxins Immunologic Factors Physiological Effects of Drugs |