Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over Pharmaceutical / Industry IXR-102-22-188 NCT00071539

Trial Description

Summary

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

Eligibility 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).

Trial Contact Information

Trial Lead Organizations/Sponsors

IVAX Pharmaceuticals, Incorporated

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00071539
Information obtained from ClinicalTrials.gov on May 27, 2008