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In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.

131I-TM601

Karen Fink, MD

Adam Mamelak, MD

Steven Rosenfeld, MD

Jan Drappatz, MD

Patrick Wen, MD

Jeffrey Olson, MD

Richard Wahl, MD

Heather Jacene, MD

Antonio Omuro, MD

Edward Pan, MD

Sean Grimm, MD

Jeffrey Raizer, MD

Nimish Mobile, MD

Marc Chamberlain, MD

Jay-Jiguang Zhu, MD

John Fiveash, MD

David Schiff, MD

Michael Edgeworth, MD

Mark Malkin, MD

Maciej Mrugala, MD

Steven Chmura, MD

Thomas Gribbin, MD

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.

This is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent malignant glioma.

The study will be conducted in two phases. Prior to initiating treatment as part of this study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During the first, Dose Escalation Phase of the study, eligible patients will be assigned in groups of 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5 weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase will be assigned to a dose determined by the experience in the first phase.

Patients in both study phases will have safety parameters evaluated continuously throughout the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days following the final study dose, and then at quarterly intervals scheduled at 3 month intervals following the first study dose, until disease progression.

A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma

TransMolecular

Susan Stewart, Vice President, Regulatory Affairs

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131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

131-I-TM-601

131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.

This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.

The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.

High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.

Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.

131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma	NCT00683761	Malignant Gliom... Glioblastoma Mu... GBM Astrocytoma Oligodendroglio...	131I-TM601	18 Years -	TransMolecular
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma	NCT00114309	Malignant Gliom... Glioblastoma Mu... GBM Anaplastic Astr... Oligo-Astrocyto... Gliosarcoma	131-I-TM-601 131I-TM601	18 Years -	TransMolecular

Spots Global Cancer Trial Database for high grade recurrent glioma