FAQ

What is the Center for Personalized Cancer Therapeutics?

We are a group of scientists and clinicians at the Icahn School of Medicine at Mount Sinai School conducting an exploratory clinical study to test a personalized medicine approach to treating cancer.

What does the study entail?

The study has several parts:

  1. The patient provides a sample of their tumor and blood.
  2. The patient’s tumor DNA is sequenced.
  3. The DNA sequence is analyzed to identify mutations that are likely to drive cancer progression.
  4. These driver mutations are introduced into a fly that then serves as a model for the patient’s tumor.
  5. The fly is then tested against a large number of FDA approved drugs and drug combinations to identify those that will counteract the effects of the mutations.
  6. Based on the results of the drug tests, clinicians recommend a novel therapeutic or combination of therapeutics that are directed specifically against each patient’s cancer. 

How long does it take?

This process currently requires about ten to thirteen months.

What will I get from this?

We will use genomic sequencing and personalized flies to model your disease with unprecedented sophistication. We will also use your model to screen for novel drugs and drug combinations. These data will allow us to produce a personalized treatment plan. Additionally, you are helping to provide the cancer community with the opportunity to test a truly new approach to cancer therapy. The more experience we gain, the more advanced our approach will become.

Who is eligible?

We are currently accepting patients with medullary thyroid cancer and colorectal cancer. Prospective patients will be evaluated to determine if their disease is a good candidate for this approach. Our evaluation will include 1) rating level of disease progression, and 2) the patient’s overall physical condition. Importantly, patients should continue their current treatments. For more details see the FAQ sections related to medullary thyroid cancer and colorectal cancer.

What if I am currently treated with FDA-approved therapy or I am on another clinical trial?

We encourage you to start a standard/FDA-approved therapy or participate in a clinical trial. We will not replace current therapy as long as it is working. However you are eligible for enrollment in the non-treatment phases of the trial, which can continue while you are in treatment with other therapies. If your current therapy stops working or if you develop significant side effects from your current therapy, and we have completed testing in our model and have results, we would then use those results from our drug screening analysis to consider a new regimen of personalized therapy.

Does my tumor need to be biopsied at Mount Sinai?

No. We can use your old biopsy/tissue for our study; our pathology team will help us with the tissue acquisition and make sure it is of sufficient quality. If your doctor is planning a biopsy of your tumor for reasons unrelated to our study, we can also use this tissue.

Can I be treated by my local oncologist with your personalized therapy?

In addition to visits with your local oncologist, you must come to Mount Sinai for scheduled follow-up visits as per study protocol. This is a very innovative approach and you will be closely followed by a physician who is experienced and familiar with this process.

Questions specific to Medullary Thyroid Cancer patients:

  • Which MTC tumors are being targeted by the Center? All forms will be considered including familial and sporadic, with RET mutations and with RAF mutations.
  • What is the best therapy for Medullary Thyroid Cancer? The best treatment for Medullary Thyroid Cancer is complete surgical removal during the first operation. Sometimes, this is not possible since many patients will already have metastases at the time of diagnosis.
  • I had Medullary Thyroid Cancer removed surgically and currently my Calcitonin and/or CEA (tumor markers) are very high. My oncologist cannot find any metastases. Am I eligible? No. In order to be eligible your cancer must be measurable with CT scan, MRI, etc.
  • What are the enrollment requirements for patients with Medullary Thyroid Cancer? In general patients must have 1) cancer that cannot be surgically cured, 2) measurable metastasis, and 3) tumor tissue available for analysis. Contact us for more details.

Questions specific to the Colorectal Cancer protocol:

  • Which colorectal cancers are being targeted by the Center? Patients whose disease shows evidence of microsatellite instability (MSI) are not eligible for this study. Aside from this, all forms of metastatic colorectal cancer will be considered.
  • What is the best therapy for colorectal cancer? For early stage disease, resection with or without adjuvant chemotherapy is the standard of care. For metastatic disease, fluoropyrimidine, oxaliplatin and irinotecan-containing chemotherapy with/without targeted therapies are the most common primary treatment. In selected individuals, surgery or other regional therapies may also be considered.
  • What are the enrollment requirements for patients with colorectal cancer? In general patients must have 1) cancer that cannot be surgically cured, 2) measurable metastasis, and 3) tumor tissue available for analysis. Contact us for more details.

How do I sign up?

Contact us for more details:
Krzysztof Misiukiewicz, M.D.
The Tisch Cancer Institute
Phone: 212-659-5609
Email: Krzysztof.Misiukiewicz@mssm.edu