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currently recruiting
Qualified patients will receive either 3 or 6 treatment
cycles with  I-TM601
and be evaluated for tumor response, survival, and safety.
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Qualified patients with confirmed recurrent or refractory
metastatic tumors will receive escalating doses of IV I-TM601
and will be evaluated to determine biodistribution and safety
of therapy.
This study is a dosimetry substudy of patients enrolled
in the TM601-002 treatment protocol and is intended to evaluate
the biodistribution (% injection dose) and clearance of I
of multiple intracavitary doses of I-TM601.
The purpose of this phase 1 clinical trial is to evaluate the safety and define the biologically active IV dose of TM601 in patients with treatment-refractory, malignant glioma. A single intravenous “imaging” dose of I-TM601 will be administered prior to treatment with TM601. Only patients demonstrating tumor specific uptake of  I-TM601 will receive further treatment. Those patients will receive intravenous infusions at one of six dose levels (0.04 mg/kg, 0.08 mg/kg, 0.16 mg/kg, 0.3 mg/kg, 0.6 mg/kg, and 1.2 mg/kg) once a week for 3 weeks. Patients will be enrolled in successive dose cohorts until either a Maximum Tolerated Dose (MTD) is defined, or perfusion changes have been demonstrated in 5 out of 6 patients in a cohort. The study is expected to take up to 18 months to complete
For more information, prospective patients
or their physicians should contact Amy Bock,
TransMolecular's Senior Director, Clinical Operations at 617-995-3050
x 316 or by email at bock@transmolecular.com
More information about TransMolecular
clinical trials currently recruiting patients can also be found
at the following websites:
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