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

Glioblastoma Multiforme Clinical Trial

Official title:

A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104091
• Other study ID #: IXR-202-22-188
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2005
• Last updated: May 20, 2011
• Start date: December 2004
• Est. completion date: June 2007

Study information

• Verified date: May 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate TP-38 at a 100 nanograms/mL concentration for sufficient activity		26 weeks	No
Secondary	Efficacy parameters including time to progression, safety, and survival		26 weeks	No