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

NCT00071539 | Completed Phase 2

• 1 other identifier: IXR-102-22-188
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Recurrent Glioblastoma Multiforme

Keywords

gross total resection

Outcome Measures

Primary Outcomes (1)

• Survival

  % patients alive

  28 weeks

Secondary Outcomes (1)

• Time to progression (TTP)

  28 weeks

Study Arms (2)

TP38 50 ng/mL

EXPERIMENTAL

Drug: TP-38

TP38 100 ng/mL

EXPERIMENTAL

Drug: TP38

Interventions

TP38 DRUG

recombinant chimeric protein

Also known as: immunotoxin

TP38 100 ng/mL

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 (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 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Glioblastoma

Interventions

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

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

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2003
• First Posted: October 29, 2003
• Study Start: October 1, 2003
• Primary Completion: January 1, 2006
• Study Completion: July 1, 2006
• Last Updated: January 20, 2012

Record last verified: 2012-01