Clinical Trial DRUG ANG1005-CLN-04
- A Phase II, Open-Label, Multi-Center Study of ANG1005 in HER2+ Breast Cancer Patients with Progressive/Recurrent Brain Metastases
- Principal Investigator
- Priya Kumthekar
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG ANG1005-CLN-04
- The main purpose of this research study is to find out if the study drug, ANG1005 can shrink tumor cells that have spread to the brain. Another purpose of this study is to evaluate the safety, effectiveness and how ANG1005 is being tolerated by patients with brain metastases.
- 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 brain metastases from breast cancer or any other disease. ANG1005 is made of a small protein molecule attached with three molecules of a chemotherapy drug paclitaxel. Paclitaxel is an FDA approved chemotherapy drug known to kill tumor cells, which is often used in treating breast cancer. Paclitaxel, like most drugs, cannot easily get into the brain due to a blood brain barrier which blocks the passage of some chemical substances from the bloodstream into the brain. Similar to a key and lock, ANG1005 is able to connect to a specific place on the blood brain barrier and the tumor cells and pass into the brain and some tumor cells. ANG1005 can stop the tumor cells from dividing which may result in tumor shrinkage; however, there is no proof that ANG1005 will cure cancer.
Some of the eligibility criteria include:
- Participants must have breast cancer that is HER2+.
- Participants must be 18 or older.
- Participants must have brain metastases (their cancer has spread to the brain) that have either returned after prior treatment or are continuing to get worse.
- Participants must have had prior treatment with whole brain radiotherapy (WBRT).
- Description of Treatment
- Participants in this study will receive the study drug ANG1005 infused through a needle inserted in the vein (IV infusion) every 3 weeks (one cycle). Patients who have been receiving Herceptin® treatment for their breast cancer may continue to receive it during the study, as determined by the doctor. Participants will continue to receive ANG1005 until their breast cancer gets worse or if they have any intolerable side effects to the study drug. The length of participation in the study will depend on how each participants responds to and tolerate the treatment.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Priya Kumthekar
- Phase I/Comparative Randomized Phase II Trial of TRC105 plus Bevacizumab versus Bevacizumab in Bevacizumab-Naïve Patients with Recurrent Glioblastoma Multiforme
- A Phase II, Open-Label, Multi-Center Study of ANG1005 in Patients with Recurrent High-Grade 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 2 Dose-Escalation Study of TPI 287 in Combination with Bevacizumab in Adults with Recurrent or Progressive Glioblastoma Following a Bevacizumab-Containing Regimen
- 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
- Phase III trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup trial.
last updated: 23-Sep-14 03:17 AM
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