 |
|
|
|
|
Treatment Name: |
|
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
|
|
|
|
|
Phase: |
|
Phase 2 |
|
|
|
|
|
|
Treatment ID#: |
|
1542 NCT00104091 |
|
|
|
|
Age Group: |
|
Adults Only |
|
|
|
|
|
|
Min Karnofsky Score: |
|
70: Cares for self, unable to perform normal activity or to do active work |
|
|
|
|
Conditions: |
|
Prior Surgery is Allowed
Prior Radiation is Not Allowed
Prior Chemotherapy is Sometimes Allowed
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).
|
|
|
|
|
|
|
Last Updated: |
|
11/13/2005 |
|
|
|
|
Tumor Types: |
|
Glioblastoma Multiforme |
|
|
|
|
|
|
|
Comments: |
|
|
|
|
|
|
|
|
Treatment Type: |
|
Chemotherapy
Immunological, Biological or Targeted Therapy |
|
|
|
|
Contact: |
|
Michael R Chicoine MD
Washington University School Of Medicine
St. Louis, MO 63110 USA
Phone: 314-362-4313
Fax:
E-mail: chicoinem@nsurg.wustl.edu
Website: |
|
|
