Breast Cancer Clinical Trial
Official title:
A Phase I Imaging and Safety Study of Intravenous 131-I-TM-601 Labeled Chlorotoxin in Patients With Recurrent or Refractory Somatic and/or Cerebral Metastatic Solid Tumors
This study is designed to evaluate the ability of intravenously (IV)administered 131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic imaging) in patients with recurrent or refractory primary solid tumors with evidence of metastatic involvement. (Refractory tumors are non-responsive to standard treatment.) The safety and tolerability of IV administered 131-I-TM-601 in this patient population will be evaluated as part of this study.
This is a multi-center, open label, non-randomized, sequential, within-patient
dose-escalation study in patients with recurrent or refractory primary solid tumors with
metastatic involvement (including brain metastases). Patients will be administered 1 to 3
(Test Doses A, B and Dose C) escalating doses of 131-I-TM-601 by intravenous (IV)
administration, with dosimetry (imaging-based evaluation of the dose reaching the target
sites) conducted prior to and following administration of each dose. Whole body dosimetry on
critical structures including, but not limited to, bone marrow, bladder, brain, liver, and
thyroid will be determined. The preliminary results from Test Dose Levels (A and/or B) for
each patient will be analyzed prior to treating patients with Dose C.
Patients will be followed until 28 days following the final dose, with a complete clinical
assessment and imaging evaluations at the final follow-up visit.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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