Advertisement

Topics

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

2014-08-27 03:53:12 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Malignant Glioma

Intervention

131-I-TM-601, 131I-TM601

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35294-3410

Status

Active, not recruiting

Source

TransMolecular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:12-0400

Clinical Trials [849 Associated Clinical Trials listed on BioPortfolio]

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

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.

A Phase II Study to Treat Advanced Malignant Glioma

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 for the treatment of Advanced Malignant Glioma.

Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma

The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.

Immunotoxin Therapy in Treating Patients With Malignant Glioma

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the ...

Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children

The purpose of the study is to confirm the optimal dose and potential toxicity of oncolytic poliovirus (PV) immunotherapy with PVSRIPO for pediatric patients with recurrent WHO grade III o...

PubMed Articles [2096 Associated PubMed Articles listed on BioPortfolio]

Effects of lentivirus-mediated CYP17A1 gene silencing on the biological activity of glioma.

Gliomas are the most common malignant primary brain tumors with poor prognosis. We attempted to explore the role of CYP17A1 in glioma progression. We demonstrated that the expression of CYP17A1 was si...

LGI1 tumor tissue expression and serum autoantibodies in patients with primary malignant glioma.

The Leucine-rich glioma inactivated 1 (LGI1) protein is thought to be implicated in malignant progression of glioma tumors, and mutations in the encoding gene, LGI1, cause autosomal dominant lateral t...

Long Non-Coding RNA in Glioma: Target miRNA and Signaling Pathways.

Glioma is one of the most common and aggressive malignant tumors of the central nervous system.

miR-497/Wnt3a/c-jun feedback loop regulates growth and epithelial-to-mesenchymal transition phenotype in glioma cells.

Glioma is one of the most frequent intracranial malignant tumors. Abnormal expression of microRNAs usually contributes to the development and progression of glioma. In the current study, we explored t...

Combination therapy of intravenously injected microglia and radiotherapy prolongs survival in a rat model of spontaneous malignant glioma.

The aim of this study was to investigate the efficacy of combination therapy with intravenously injected microglia (MI) and radiotherapy (RT) for rat malignant glioma.

Medical and Biotech [MESH] Definitions

A malignant BRAINSTEM neoplasm of the PONS. They are more commonly found in children than adults.

Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.

Benign and malignant neoplasms that arise from the optic nerve or its sheath. OPTIC NERVE GLIOMA is the most common histologic type. Optic nerve neoplasms tend to cause unilateral visual loss and an afferent pupillary defect and may spread via neural pathways to the brain.

A fatty acid-binding protein expressed by ASTROCYTES during CENTRAL NERVOUS SYSTEM development, and by MALIGNANT GLIOMA cells. It is also expressed by ASTROCYTES in response to injury or ISCHEMIA, and may function in repair of the MYELIN SHEATH.

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

More From BioPortfolio on "131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial