Clinical Trial DRUG ANG1005-CLN-03
- A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients with Recurrent High-Grade Glioma
- Principal Investigator
- Priya Kumthekar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG ANG1005-CLN-03
- The main purpose of this research study is to see if an investigational drug, ANG1005, can shrink tumor cells in patients with high-grade glioma. Another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of ANG1005 in patients.
- Gliomas are cancer cells that come from the supportive (“gluey”) tissue of the brain. Gliomas are “graded” from 1 to 4 on how normal or abnormal the cells look. High grade gliomas are those given a Grade 3 or Grade 4. High grade gliomas are the most resistant to treatment. The current standard of care (radiotherapy and temozolomide) provides some benefit but additional treatments are needed to improved survival. In addition, many drugs are not designed to get into the brain and are not able to reach the tumor cells in the brain. Angiochem has developed a drug that has been shown to get into the brain tumor cells in 3 studies: one study in patients with glioblastoma, one study in patients with brain metastases from solid tumors and one study in patients with brain metastases from breast cancer. ANG1005 is an investigational drug which means that it is not approved by the United States (U.S.) Food and Drug Administration (FDA) to treat high-grade gliomas. ANG1005 has a peptide and three molecules of a chemotherapy agent paclitaxel. A peptide is a small protein molecule. Paclitaxel is a chemotherapy drug often used in treating various cancer types. Paclitaxel, like most drugs, cannot easily get into the brain due to a blood brain barrier which restricts the passage of some chemical substances and microscopic objects in the bloodstream. However, the peptide on the ANG1005 is specifically designed to bring the drug into the brain and the brain tumor cells. Similar to a key and lock, the peptide on ANG1005 connects with a receptor located on the surface of the blood brain barrier and on the tumor cells, allowing ANG1005 to enter into the brain and tumor cells. ANG1005 stops tumor cells from dividing which may result in tumor shrinkage.
Some of the eligibility criteria include:
- Participants must have high grade glioma (grade III or IV).
- Participants must be 18 or older.
- Participants may not have had more than three relapses of their cancer.
- Description of Treatment
- In this study, ANG1005 will be administered as an intravenous (IV) infusion once every 3 weeks. ANG1005 will be administered until disease progression or unacceptable adverse events (AEs) are observed. Participants will remain on study medication under this protocol for a maximum period of one year unless they develop tumor progression or develop unacceptable toxicity.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Priya Kumthekar
- A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation
- A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects with Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma
- A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Combination with Radiation Plus Temozolomide or Temozolomide Alone for Subjects with Glioblastoma Multiforme
- Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma
- A Phase II Trial of Bevacizumab in Patients with Recurrent Solid Tumor Brain Metastases Who Have Failed Whole Brain Radiation Therapy
- Randomized Phase II of Concurrent Bevacizumab & Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
last updated: 11-Feb-16 11:05 AM
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