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Clinical Trials Considering or participating in research studies

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Old Mon May 13, 2019, 07:31 PM
JoMac53 JoMac53 is offline
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Vitamin C Trial

I've contacted them about this trial because I have a TET2 mutation but they're currently amending the trial so enrollment is not open. However, they encouraged me to send them my records so if I'm accepted they could hit the ground running to get me in the trial once they're open again.
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MDSF Center of Excellence, Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, is conducting a study on high dose vitamin C and its effect on the TET2 mutation in patients with MDS.

Vitamin C may “tell” faulty stem cells in the bone marrow to mature and die normally, instead of multiplying to cause blood cancers.

You may be eligible for this study if you meet the following criteria:

Conditions:
• Myelodysplastic Syndrome with positive TET2 mutations
• Between 18 - 99 Years
• Male or Female
• Myeloblasts account for less than 20% of leukocytes
• Adequate organ function

If you are interested, please contact the MDSF or the Center of Excellence directly (Dr. Raoul Tibes via email at Raoul.Tibes@nyulangone.org).
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Joanne, 65F, Primary MDS-EB1, Pancytopenia, 8/17. Weekly CBC, Granix shot if ANC below 1.0.
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Old Wed May 15, 2019, 01:21 PM
JoMac53 JoMac53 is offline
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Here is more information about this trial. Both my hematologist and my bone marrow doctor said they would have no objections to this. But I can't travel to NY like they require so I won't be doing it. This is a response to my inquiry:

"Currently the trial is not open to accrual and enrollment is put on hold due to an amendment for the protocol. We are expecting the trial to reopen sometime in June, but we unfortunately do not have an exact date. We do not encourage you to wait if you have an alternative treatment plan that is available to you at this time.

The trial treatment is high dose vitamin c. The treatment runs continuously every day over 24 hours for 5 days in each cycle (cycle = 28 days). Due to the continuous infusion, patients are required to get a PICC line or mediport placed. Patients are also required to come into clinic every day for the first week (Monday to Friday) of each cycle and weekly for the rest of the cycles. The maximum amount of treatment on this trial is 4 cycles (approximately 4 months). For more information about this trial, I have attached the informed consent for you to read.

Prior to enrolling a patient, our team must screen and check eligibility requirements to ensure it is safe to have the patient receive treatment. For eligibility and screening purposes, we are required to review your medical records which outlines your doctor’s note, medical history, lab results, pathology reports, current medications, scans (if any), and other pertinent information regarding your health.

As you are aware for this trial, the patients are required to have myelodysplastic syndrome expressing the TET2 mutation in order to be qualified. If you are still interested in participating in the trial or would like a consultation with Dr. Tibes, at your best convenience, please send us your Full Name, Location to where your medical records are, name of your hematologist, where you currently reside, and best number(s) to reach you. Thank you for your time and we look forward to hearing back from you."

I have a copy of the informed consent, if anyone wants a copy, send me a pm.
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Joanne, 65F, Primary MDS-EB1, Pancytopenia, 8/17. Weekly CBC, Granix shot if ANC below 1.0.
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Old Wed May 15, 2019, 06:32 PM
Marlene Marlene is offline
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Thanks for posting the trial protocol. It's a shame you have to travel for it. It seems like this would be low-risk trial and could be done locally. So many alternative clinics do high dose IV Vitamin C but it's not continuous for 5 days.

Do you know how do they administer a 24 hour continuous infusion and what the dosage of Vitamin C is?
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Marlene, wife to John DX w/SAA April 2002, Stable partial remission; Treated with High Dose Cytoxan, Johns Hopkins, June 2002. Final phlebotomy 11/2016. As of January 2017, FE is 233, HGB 11.7, WBC 5.1/ANC 4.0, Plts 146K.
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Old Wed May 15, 2019, 08:25 PM
JoMac53 JoMac53 is offline
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From the informed consent, "You will receive Vitamin C as a continuous infusion, which is given to you intravenously (in your vein) using a pump, which you will wear. Each continuous infusion will last for 5 days in a row, and the pump will be changed every 24 hours."

I don't see anything that tells what the dose is. They do say if the trial doctor thinks you're receiving clinical benefit from the Vitamin C, you will undergo a
second, third, or fourth 4-week cycle of treatment, as long as you continue to receive benefit, up to 16 weeks.
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Joanne, 65F, Primary MDS-EB1, Pancytopenia, 8/17. Weekly CBC, Granix shot if ANC below 1.0.
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