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

NCT00104091 | Completed Phase 2

• 1 other identifier: IXR-202-22-188
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Glioblastoma Multiforme

Keywords

Gross Total Resection; Convection Enhanced Delivery; Recurrent Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity

  26 weeks

Secondary Outcomes (1)

• Efficacy parameters including time to progression, safety, and survival

  26 weeks

Study Arms (1)

1

EXPERIMENTAL

40 mL of TP-38 at a 100 nanograms/mL concentration

Drug: TP-38

Interventions

TP-38 DRUG

TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

transforming growth factor(alpha)-Pseudomonas aeruginosa exotoxin (38)

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2005
• First Posted: February 23, 2005
• Study Start: December 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 23, 2011

Record last verified: 2011-05