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Janelle · 07-03-2008, 10:06 PM

Below is the email that I sent to Dr. Mittendorf with more questions. I'll post her response when I recieve it.

"Dr. Mittendorf,
To clarify (and beat a dead horse)....the phase 2 trial at MD Anderson requires that 50% of the enrollees will be randomized to a GM only arm which is possibly similar to a placebo arm, correct? And it is the phase II of the E75 trial that is being started?

Are you still the point of contact for the MD Anderson trial?

I have more questions about the history of the phase II trial. Should I contact a POC other than you to get these answers? Here are my questions:

I noticed through some research that one person who enrolled in what I believe to be the was phase I HER2 vaccine trial trial had to discontinue the trial due to cardiac toxicity. I am not sure if she was enrolled in phase I of the E75 trial or a trial at another institution for metastatic patients. Do you know of any people experienced cardiotoxicity in the phase I trial of the E75 vaccine or any other vaccine trials? If so, were these patients heavily pretreated with cardiotoxic chemo (specifically with A/C chemo) or targeted therapies prior to enrollment? And, did their heart function improve once they discontinued the trial? I assume all the enrollees had normal heart function results to qualify for the phase I study but please let me know if this assumption may be incorrect.

What was the average age of the phase I participants? Do you think age was a factor in any cardioctoxicity if any patients who had to discontinue the respective vaccine trial due to this complication? (Knock on wood, but as far as I know, my heart function is good (high normal).) I am also under 40 which may or may not help me tolerate the drugs....and I was a jogger for 15 years prior to diagnosis.

To the best of your knowledge, are you aware of any enrollees in HER2 vaccine trials had to drop out due to significant adverse events other than cardiotoxicty, what were those events? Did they recover?

Since the phase 1 trial at Mary Crowley is in part studying the safety of the multipeptide vaccine as you pointed out and I will be an early enrollee I am trying to determine if the other vaccine trials are a reasonable basis for comparison as I attempt to assess the risks that I will take by enrolling in this trial. Or do you feel that the other vaccine trials are not good for safety comparisons for other reasons? If so, what are those reasons?

I understand and acknowledge that the phase 1 trial is designed to test the safety of the drug and you may be unable to give me any reassurance on the safety issues. But if you can give me any guidance as to how I should proceed to think about these safety issues that would be helpful. Otherwise, can you recommend a way for me to do a comparison myself or is the date not available to the public yet on the other vaccine trials?

My very conservative oncologist did not seem to be overly concerned about the safety issues with either trial the MD Anderson trial or the Mary Crowley trial based on the information that I gave her which reassured me. But I am very analytical by nature so I am interested in as much information as is available to me. I will ask Neil for more information on the phase I trial unless you are the better person for me to get such information. Feel free to pass this email along to Neil. I am not copying him on this email as many of my questions involve the MD Anderson trial in which he may have involvement.

If I chose to enroll in the MD Anderson trial, how long will the trial last? Will I need to travel to Houston every month for 6 months? Or are the vaccines administered over a more compressed time period? How long will I be required to stay in Houston for each vaccine administration?

I would like any updated information on both trials that you have not already provided to me so I may review the most recent information again with my oncologist.

By the way, one more question which is off topic....Has MD Anderson started giving Zometa to early stage breast cancer patients to prevent bone mets or do you think they will begin to do so? I understand if you can't answer this question as I am not a patient at MD Anderson but I am asking in terms of generalities and not seeking information specific to my own treatment plan."

Thanks again!
Janelle

07-03-2008, 10:06 PM	#2
Janelle Senior Member Join Date: Nov 2007 Location: Brentwood, CA Posts: 76	Below is the email that I sent to Dr. Mittendorf with more questions. I'll post her response when I recieve it. "Dr. Mittendorf, To clarify (and beat a dead horse)....the phase 2 trial at MD Anderson requires that 50% of the enrollees will be randomized to a GM only arm which is possibly similar to a placebo arm, correct? And it is the phase II of the E75 trial that is being started? Are you still the point of contact for the MD Anderson trial? I have more questions about the history of the phase II trial. Should I contact a POC other than you to get these answers? Here are my questions: I noticed through some research that one person who enrolled in what I believe to be the was phase I HER2 vaccine trial trial had to discontinue the trial due to cardiac toxicity. I am not sure if she was enrolled in phase I of the E75 trial or a trial at another institution for metastatic patients. Do you know of any people experienced cardiotoxicity in the phase I trial of the E75 vaccine or any other vaccine trials? If so, were these patients heavily pretreated with cardiotoxic chemo (specifically with A/C chemo) or targeted therapies prior to enrollment? And, did their heart function improve once they discontinued the trial? I assume all the enrollees had normal heart function results to qualify for the phase I study but please let me know if this assumption may be incorrect. What was the average age of the phase I participants? Do you think age was a factor in any cardioctoxicity if any patients who had to discontinue the respective vaccine trial due to this complication? (Knock on wood, but as far as I know, my heart function is good (high normal).) I am also under 40 which may or may not help me tolerate the drugs....and I was a jogger for 15 years prior to diagnosis. To the best of your knowledge, are you aware of any enrollees in HER2 vaccine trials had to drop out due to significant adverse events other than cardiotoxicty, what were those events? Did they recover? Since the phase 1 trial at Mary Crowley is in part studying the safety of the multipeptide vaccine as you pointed out and I will be an early enrollee I am trying to determine if the other vaccine trials are a reasonable basis for comparison as I attempt to assess the risks that I will take by enrolling in this trial. Or do you feel that the other vaccine trials are not good for safety comparisons for other reasons? If so, what are those reasons? I understand and acknowledge that the phase 1 trial is designed to test the safety of the drug and you may be unable to give me any reassurance on the safety issues. But if you can give me any guidance as to how I should proceed to think about these safety issues that would be helpful. Otherwise, can you recommend a way for me to do a comparison myself or is the date not available to the public yet on the other vaccine trials? My very conservative oncologist did not seem to be overly concerned about the safety issues with either trial the MD Anderson trial or the Mary Crowley trial based on the information that I gave her which reassured me. But I am very analytical by nature so I am interested in as much information as is available to me. I will ask Neil for more information on the phase I trial unless you are the better person for me to get such information. Feel free to pass this email along to Neil. I am not copying him on this email as many of my questions involve the MD Anderson trial in which he may have involvement. If I chose to enroll in the MD Anderson trial, how long will the trial last? Will I need to travel to Houston every month for 6 months? Or are the vaccines administered over a more compressed time period? How long will I be required to stay in Houston for each vaccine administration? I would like any updated information on both trials that you have not already provided to me so I may review the most recent information again with my oncologist. By the way, one more question which is off topic....Has MD Anderson started giving Zometa to early stage breast cancer patients to prevent bone mets or do you think they will begin to do so? I understand if you can't answer this question as I am not a patient at MD Anderson but I am asking in terms of generalities and not seeking information specific to my own treatment plan." Thanks again! Janelle __________________ Janelle Diagnosed October 2006 at age 37 wtih grade 3 IDC and high grade DCIS Stage 1c triple positive, no node involvement but vascular invasion multifocal disease Lumpectomy November, 2006 A/C every 3 weeks (started Jan., 2007 and finished March 2007); followed weekly Taxol (finished June 2007) concurrent with Herceptin (finished March 2008); Bilateral Mast with immediate recon in Sept 2007; finished recon Dec. 2007 Started 5 years of tamoxifen Nov. 2007; started peptide vaccine clinical trial at MD Anderson October 2008 and finished active part of trial in April 2009 (monthly injections of AE37 peptitde (HLA type specific) with GM-CSF or GM-CSF alone depending on if I was in experimental or control group); started Zometa infusions June 25, 2009- 4mg every 6 months for 3 years (taking it "off-label" to try to prevent mets)