Dr. Dung Le, Principal Investigator
The Lustgarten Foundation is funding efforts related to a clinical trial/research study being led at the Johns Hopkins Kimmel Cancer Center to test the effectiveness of Merck’s Pembrolizumab* immunotherapy drug in patients whose tumors have a unique mutation. This mutation can only be identified through testing of tumor tissue for a characteristic genetic signature called “MSI” (microsatellite instability), found in approximately 2 percent of pancreatic cancer patients. A recent research study led at Johns Hopkins demonstrated that patients with a variety of advanced cancers whose tumors had this unique genetic signature responded to Pembrolizumab, even when other forms of therapy were not effective.
Pancreatic cancer patients interested in this clinical trial/research study should speak with their physicians about having their tumors tested for MSI. ProPath performs this testing, and samples can be sent to ProPath according to the instructions below. The Lustgarten Foundation has agreed to pay for this testing. Moreover, those patients who test positive and whose disease is resistant to other therapies may be eligible for this clinical trial/research study at Johns Hopkins using Pembrolizumab. Patients will receive tumor testing, treatment and clinical care free of charge. However, patients may incur other costs. The research study/trial may be limited, so patients who test positive for the MSI mutation will be evaluated on a first come, first serve basis.
For more information about this clinical trial, call The Lustgarten Foundation at 1-866-789-1000.
*Pembrolizumab is not yet FDA approved for the treatment of MSI pancreatic cancer.
Instructions for submitting tissue for MSI testing
- Identify the pathology practice that performed the original pathology services.
- To request tissue for testing, you will need the following: patient’s name, case number, and at least one additional patient identifier (date of birth, SSN, etc).
- Contact the pathology practice to request that material for testing be sent to ProPath. Note that different institutions may allow written, verbal, email, or on-line requests.
- Complete the Authorization for Disclosure of Protected Health Information Form and FAX it to 214-237-1887.
Testing cannot be completed until this form has been received.
This document ( Microsoft Word / PDF Form) can be used as a template for requesting tissue blocks.
Be sure to request all of the following:
- Tissue block (formalin-fixed, paraffin-embedded, FFPE tissue block) with representative material
- The original H&E stained slide
- Copy of the pathology report
Have the material shipped to:
Attn: Molecular Diagnostics Laboratory, NCT01876511
1355 River Bend Drive
Dallas, TX 75247
- Some practices may take up to one week to retrieve and ship the material for testing.
- ProPath will return all unused materials to the institution within 30 days of receipt.
Contact us with any questions by calling 1-800-258-1253.