Completed

Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors

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What is being tested

TP-38

+ TP38

Drug
Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.

Official TitleSafety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors 
NCT00071539
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

56 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers