New Phase II Vaccine Trial information

[Janelle]

Hi,
I contacted MD Anderson about enrolling in the E75 vaccine trial but learned that I probably won't qualify for the Phase III trial as it is not anticipated to start enrolling participants until the fall and I will likely be too far out from treatment to qualify. I learned though that they are going to be starting a phase II study on a cousin vaccine and that study has already starting enrolling patients at a couple of institutions that are participating which include Walter Reed, Brookline (a Texas military facility), Mary Crowley Cancer Center in Dallas and Wake Forest. MD Anderson believes that will start enrolling patients in May.

I spoke with Dr. Mittendorf who is the doctor who is heading up the cousin vaccine study at MD Anderson. She is looking for as many patients to enroll as possible. She is going to send me her contact info by email this afternoon and she said I could post it here and people can contact her directly.

Here is some general info on the study....(a lot of the scientific stuff was lost on me)...

1) enrollment criteria:
Her2 positive (any level of Her2 positivity is acceptable)
High risk for recurrance because of one of the following: node positive; tumor between 2cm-5cm; grade 3; lympovascular invasion, or ER or PR negative
Must have completed standard care of therapy
Must enroll between 1-6 months after primary treatment has ended (this includes herceptin treatments)
Must be NED
Must be immunolgically intact (they test for this)

2) If you are ER/PR positive, you can stay on tamoxifen if you are on it.

3) This is a Phase II study. The Phase I study had only 15 patients. In terms of adverse events, there was no horrible toxicity associated with the vaccine. There were some mild adverse events which are rated on a scale of 1-5 (a 5 is death). Of those who received the vaccine a few had grade 2 adverse events which included flu like symptoms and bone pain. There were also local adverse events which is a rash at the injection site which they like to see.

4) There are 4 arms of the study. Based on your HLA status which can be either A2 positive or A2 negative, the participatants will be divided into 2 groups. 50% oft hose who are A2 positive will receive the vaccine and the remainder will receive something called GM alone which the doctor thinks will show no benefit in this group.

If you are A2 negative, you will receive a slighly different type of vaccine or GM alone.

If you are A2 positive or A2 negative, you will be randomized into either a vaccine group which the doctor believes is promising or you will only get the GM alone treatment which sounds like they expect it to do nothing.

You must be willing to travel to one of these cancer centers every month for 6 months to receive the vaccine. <!--IBF.ATTACHMENT_289820-->

I will post Dr. Mittendorf's contact info as soon as I recieve it. Also she is going to email me some info on the old trial results and maybe some info on this "cousin" trial. If you PM me your email addresses, I will forward you the info. <!--IBF.ATTACHMENT_289815-->

[DonnaD]

I am interested in more info, when you rec info from Dr. Mittendorf. I am getting close to not qualifying for the trail since I ended Herceptin the end of Dec. Please get me the info ASAP. Traveling could be an issue also.

Thanks for getting the info to us.
Donna

[Janelle]

Donna,
I will absolutely post more info when I receive it. I was expecting a follow up email today from Dr. Mittendorf but I haven't received anything yet. You could try to look her up on the MD Anderson website. I'm sure she will respond to you asap. She is interested in enrolling as many people as possible.

Also, you could look into doing the trial at a center that is already enrolling patients if timing is an issue for you. MD Anderson is just the most convenient location for me.

Janelle

[Janelle]

Here is the email that I just received from Dr. Mittendorf:

Ms -

It was nice chatting with you today regarding our program using HER2/neu-derived peptide vaccines. As we discussed, it will likely be late summer or early fall before Apthera launches the phase III trial for NeuVax (E75). The trial we are close to launching at MD Anderson is the AE37/GP2 efficacy (phase II) trial. I have attached a powerpoint presentation that I just gave to a group and the trial schema is slide #25. Much of the data in this powerpoint talk is published in our Clinical Cancer Research paper which I have also attached for your review. There is some unpublished data in the talk so I would ask that you not distribute copies of this presentation. If you would like to review it with your treating oncologist that would be fine and I would be happy to answer any questions either of you may have. Also, I am unable at this time to provide copies of the manuscript detailing the AE37 phase I trial but it is in press for publication in the Journal of Clinical Oncology. The manuscript detailing the GP2 phase I trial is in preparation.

WIth respect to inclusion and exclusion criteria for the trial, I have listed those below.

You asked that I provide contact information and that is included at the bottom of this email. The most reliable way to get in touch with me is via email.

I will be in touch as more details regarding our trial start date become sorted out.

Beth



G.3.1 Inclusion Criteria

1. NP or high-risk NN breast cancer patients. The latter is defined as any one of the following: T2, grade 3, lymphovascular invasion, ER/PR negative, or N0 (i+).
2. HER2/neu-expressing tumor (IHC 1-3+ and/or positive FISH >1.2)
3. Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
4. Clinically cancer-free (no evidence of disease)
5. Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies.
6. Immunologically intact by recall anergy testing (defined below)
7. Good performance status (defined below)
8. Capable of informed consent

G.3.2 Exclusion Criteria

1. HER2/neu- breast cancers (IHC 0)
2. Clinical and/or radiographic evidence of residual or persistent breast cancer
3. Anergic by the Mantoux panel of recall antigens
4. Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
5. In poor health (Karnofsky <60%, ECOG >2)
6. Tbili >1.8, creatinine>2, hemoglobin<10, platelets<50,000, WBC<2,000
7. Active pulmonary disease requiring medication to include multiple inhalers
8. Pregnancy (urine HCG)
9. Breast feeding
10. History of autoimmune disease

Elizabeth A. Mittendorf, M.D.
Department of Surgical Oncology
U. T. M.D. Anderson Cancer Center
1515 Holcombe Blvd. Unit 444
Houston, TX 77030
Phone: (713)792-7216
Fax: (713)745-5235
Pager: (713)404-2202
email: eamitten@mdanderson.org