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

Phase 2

Completed

• Conditions: Recurrent Glioblastoma Multiforme
• Interventions: Drug: TP-38; Drug: TP38

• Registration Number: NCT00071539
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2003-10-28
• Study First Submitted QC: 2003-10-28
• Study First Posted: 2003-10-29
• Primary Completion: 2006-01
• Study Completion: 2006-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TP38 50 ng/mL	TP-38	-
TP38 100 ng/mL	TP38	-

Primary Outcome Measures

Name	Time	Method
Survival	28 weeks	% patients alive

Secondary Outcome Measures

Name	Time	Method
Time to progression (TTP)	28 weeks	An independent review committee will review MRI scans and will be blinded to the dose each patient received.