Safety and efficacy study to treat recurrent Grade 4 malignant brain tumors
This study is currently recruiting patients.
Sponsored by: |
IVAX Research |
Information provided by: |
IVAX Research |
Purpose
Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating
malignant glioma.
Condition
|
Treatment or Intervention |
Phase |
Recurrent Glioblastoma Multiforme
|
Drug: TP-38
|
Phase II
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Expected Total Enrollment:
56
Study start: October 2003
Eligibility
Ages Eligible for Study:
18 Years and above,
Genders Eligible for Study:
Both
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 intracavatory 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).
Location
and Contact
Information
California University of California San Francisco, San Francisco,
California,
94143,
United States; Recruiting
Illinois Evanston Northwestern Healthcare Evanston Hospital, Evanston,
Illinois,
60201,
United States; Recruiting
Patricia Lada
847-570-2025
plada@enh.org
Nina Paleologos, MD, Principal Investigator
Kentucky University of Kentucky, Lexington,
Kentucky,
40356,
United States; Recruiting
Bonnie Rosbolt, PharmD
859-323-8199
Byron Young, MD
859-323-5864
Byron Young, MD, Principal Investigator
Minnesota University of Minnesota, Minneapolis,
Minnesota,
55455,
United States; Recruiting
Walter Hall, MD
612-624-6666
Walter Hall, MD, Principal Investigator
More Information
Study ID Numbers:
IXR-102-22-188
Record last reviewed:
January 2004
Record first received:
October 28, 2003
ClinicalTrials.gov Identifier:
NCT00071539Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10