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completed
glioma clinical trials
A phase I/II open label, single-dose
study of intracavitarily administered  I-TM601
in adult patients with recurrent high-grade glioma was completed.
Single doses ranging from 0.25 mg TM601 plus 10 mCi I to 1.00
mg TM601
plus 10 mCi I
were administered to 18 patients through an intracavitary route
following surgical tumor de-bulking. Patients had recurrent glioma
after receiving standard therapy.
Results showed that I-TM601
was well tolerated up to the maximum dose of 1.00 mg TM601 plus
10 mCiI.
No Grade 3 toxicities assessed as “probably related”
to treatment were observed, therefore the dose of 131I TM601
was escalated up to the protocol’s maximum dose of 1.00
mg TM 601/10mCi I.
No adverse events (AEs) occurred which required interruption of
I
TM601 infusion.
Efficacy was not the primary end point of the trial.
However, imaging and survival evaluations revealed the following:
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Two patients who had
received 0.50 TM601 plus 10 mCi I
had >50% reductions in tumor size following treatment. |
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Eighteen (of 18) patients were still alive
at 4 months follow-up. |
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Eight patients were still alive at 6 months
follow-up. |
| • |
Five patients survived beyond 12 months. |
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Two patients achieved long-term (> 3 years)
survival. |
Dosimetry studies were also conducted as part of
the phase I/II study. Results demonstrated that, while high radiation
doses were delivered via TM601 to the tumor cavity, minimal radiation
reached other body tissues, indicating that dosages can be substantially
increased without harming normal tissue.
In the first sequence of this phase II trial,15 patients with
high-grade, recurrent, high-grade were assigned to one of 4 treatment
groups who received escalating doses of intracavitarily administered
I-TM601.
Three of the four groups were assigned to receive 3 doses; the
4th group was assigned to receive 6 doses.
I-TM601
was safe and well tolerated at all doses studied. Thirteen serious
adverse events occurred, 8 of which were deemed as unrelated to
I-TM601
and 5 of which were deemed possibly related to treatment. No dose
limiting toxicities occurred in any treatment group; adverse events
were typical of those expected in patients with high-grade gliomas.
Based on the results of this study, a dosing regimen of 40 mCi/0.8
mg TM601 was chosen for the second sequence of the study. The
patients continue to be followed for tumor progression and survival.
* The completed dose-escalating study, which included
15 patients and was designed to evaluate safe dosage ranges for
I-TM601,
was the first sequence of a larger ongoing phase II clinical trial
evaluating the efficacy and safety of I-TM601
in patients with high-grade glioma.
For information about the second sequence
(safety and efficacy) of the phase II trial, and other ongoing
clinical trials, click
here.
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