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TM-601 Trial
The Department of Neurosurgery at the University of Washington Medical
Center is currently enrolling patients in a Phase II clinical trial involving
adult patients with recurrent malignant glioma: A Phase II Open-Label,
Multiple-Dose Study of Intracavitary Administered 131I-TM-601 In Adult
Patients with Recurrent High-Grade Glioma. Participants will receive an
investigational radiopharmaceutical drug called 131I-TM-601. TM-601 is
a small synthetic peptide that specifically targets and binds to glioma
tumor cells, concurrently delivering the radioactive iodine isotope 131I.
The principal goals of this study are to:
- Determine the Maximum Tolerated Dose of 131I-TM-601 administered intracavitary
to patients with recurrent high-grade glioma.
- Determine the toxicity of a three (3) and six (6) dose cycle of 131I-TM-601
administrations into the tumor resection site of patients with recurrent
high-grade glioma
- Evaluate the 6 and 12-month rate of progression and survival of patients
with recurrent high-grade glioma treated with a three (3) or six (6) dose
cycle of 131I-TM-601
- Evaluate the overall time to progression and death of patients with recurrent
high-grade glioma treated with either a three (3) or six (6) dose cycle
of 131I-TM-601
TransMolecular, Inc. TM-601
A PHASE II OPEN-LABEL, MULTIPLE-DOSE STUDY OF INTRACAVITARY ADMINISTERED
131I-TM-601 IN ADULT PATIENTS WITH RECURRENT HIGH-GRADE GLIOMA
PI: ROBERT ROSTOMILY MD/NEUROSURGERY 206-543-3570
RESEARCH RN: LISA MANDELL, 206-616-8967
Criteria for Inclusion:
Disease Characteristics:
- Patient has had prior histologically confirmed diagnosis of malignant
glioma (grade 3 or 4, including anaplastic astrocytoma, gliosarcoma, glioblastoma
multiforme or malignant oligoastrocytoma)
- Glioma has progressed or recurred following radiotherapy that
was no less than 50 Gy (+/- chemotherapy; +/- surgery)
- The patient is a candidate for re-operation independent of intended
treatment with 131 I-TM-601
- Imaging shows recurrent, unilateral, supratentorial tumor(s).
Resection of tumor(s) must result in one resection cavity which can be
resected in a single contiguous surgical cavity. The presence of non-contiguous
satellite lesions is an exclusion.
- Based on the neurosurgeon's judgment, a single surgical
cavity of less than 100 cc in volume will be created and result in removal
of ≥ 80% of the tumor burden (based on T1 weighed gadolinium image)
- There is no diffuse leptomeningeal disease
- For patients with previous radio-surgery or enhanced radiotherapy,
based on the neurosurgeon’s judgment, the area of enhancement can
be removed during surgery
- Based on the neurosurgeon’s judgment, there is no anticipated
physical connection between the post-resection tumor cavity and the cerebral
ventricle
Patient Characteristics:
- Male or female adult patients 18 years of age or older or as defined
by state law
- Patient has recovered from toxicity of prior therapies; an interval
of at least 12 weeks must have elapsed since the completion of the most
recent course of radiation (including radiosurgery and enhanced radiotherapy),
treatment with Gliadel® or the previous surgery, while at least
4 weeks must have elapsed since the completion of a non-nitrosourea
containing chemotherapy regimen and at least 6 weeks since the completion
of a nitrosourea containing chemotherapy regimen
- Patient has a Karnofsky Performance Status ≥ 60%
- Patient’s life expectancy, based on the Investigator’s
judgment, is at least 3 months
- Patient has no uncontrolled seizures or other neurological conditions
which would interfere with evaluation
- Patient is not currently receiving, or is not anticipated to receive,
concomitant anticancer agent(s) during the course of this study
- Patient is able to give voluntary written informed consent and can
comply with the study protocol
For more information about this trial please contact:
Research RN: Lisa Mandell - 206-616-8967
or email: neuroonc@u.washington.edu
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