Herceptin Vaccine Trial Preliminary Results Very Promising

[julierene]

The statistics look great. Can any of you give your own experiences with the Herceptin Vaccine Trial?


http://www.medscape.com/viewarticle/517601
HER2/neu Vaccine May Curb Breast Cancer Recurrence




By David Douglas

NEW YORK (Reuters Health) Nov 22 - A vaccine based on a peptide from the HER2/neu protein prompts a specific immune response and may prevent clinical recurrences in certain disease-free patients who have been treated for node-positive breast cancer (NPBC), according to researchers.

"While our results are preliminary," lead investigator Dr. George E. Peoples told Reuters Health, "we are encouraged that this type of trial, evaluating cancer prevention as opposed to cancer treatment, will ultimately reveal the power, and appropriate future use, of cancer vaccines."

In the October 20th issue the Journal of Clinical Oncology, Dr. Peoples of Walter Reed Army Medical Center, Washington, DC and colleagues note that E75 is an immunogenic peptide from the HER2/neu protein that is highly expressed in many breast cancers. "Our clinical trials are investigating E75 mixed with GM-CSF as a simple vaccine strategy," the researchers explain.

The team used the vaccine in 24 HLA-A2+ patients with NPBC, while a further 29 HLA-A2- NPBC patients acted as controls. Vaccinated patients showed clonal expansion of E75-specific CD8+ T cells, which lysed HER2/neu-expressing tumor cells.

At 22 months' median follow-up, the only two deaths that had occurred were in the control group. Disease-free survival was 85.7% in the vaccinated group and 59.8% in controls. The recurrence rate was 8% in the vaccinated group and 21% in controls.

Dr. Peoples pointed out that the "reduction in recurrences in our vaccinated breast cancer patients is similar to the recent reports using Herceptin - trastuzumab - a monoclonal antibody, that targets the same HER2/neu protein as our vaccine."

He added: "Preclinical data suggest that the two may be synergistic, and, therefore, the combination of Herceptin and our vaccine may be even more effective in preventing recurrences in high risk breast cancer patients."

In an accompanying editorial, Drs. Lupe G. Salazar and Mary L. Disis of the University of Washington, Seattle, call the study data "provocative" and note that it remains to be determined which patients might benefit most from vaccination.

J Clin Oncol 2005;23:7536-7545.

[jhandley]

Testing for the HLA A2 + ..was that only available through the trial? This E75 sounds very good.

Jackie

[Sherryg683]

Damn, that sounds promising. I wonder if it's good for us mets gals, I would think so. I am going to talk to my oncologist about it Friday...sherryg683

[Lolly]

Hi all; I was in the University of Washington/Seattle Her2 Vaccine w/Herceptin trial last spring/summer. This trial used a peptide vaccine, and volunteers had to be Stage IV and HLA-A2 positive. Although I did recurr later that summer, I still think the vaccine was a positive for me in several respects; I was able to contribute to the data pool, and it's possible the vaccine helped contain my recurrence to just the same lymph nodes I've been dealing with since my first recurrence in 2001. Here's a link to the trial info that I was enrolled in, you may have already seen this by going to the Clinical Trials page on this site, after first clicking on Index...

http://www.medical.washington.edu/st...tudy=038845B01

[Cynthia]

Friends,

I previously participated in the breast cancer vaccine trial at Walter Reed. I was in the node positive arm of the trial (4 nodes) and am pleased to report, so far so good. I believe that the Walter Reed (for military active duty and dependents)/Windber (for civilians/non-dependents) trial requires that the patient be NED.

I understand that one of the goals of the trial is to develop a vaccine to ultimately give to people who are at high risk for developing B/C to prevent it from ever occurring, and to give it to early stage B/C patients in the hopes of preventing a recurrence. Originally the trial was not open to patients who previously received Herceptin (I had not gotten Herceptin prior to participating in the vaccine trial, but I am receiving it now. Dr. Peoples, who heads the vaccine trial, encouraged me strongly to get Herceptin after the Herceptin trial results were announced at ASCO -- which happened after I finished the vaccine trial). Given that so many folks are now receiving Herceptin, enrollment in the vaccine trial went down dramatically because fewer Her 2+ patients could meet the eligibility requirement of not having had Herceptin. I understand that they were looking to amend the requirement that patients not have Herceptin prior to participating in the vaccine trial, though I don't know where they stand in that process. If anyone is interested, I would be happy to find out.

I would like to plug the amazing efforts being undertaken in our military hospitals to fight breast cancer. As a result of wonderful advocacy by the National Breast Cancer Coalition and others, Congress has funded sizable dollars to be used by the Department of Defense in the fight against breast cancer. The fight is ongoing (please see the information below if you are interested in helping the cause on the political front). I am consistently stunned and thrilled to observe how much our military doctors and scientists are doing to help us beat this disease. Their dedication and determination is wonderful.

Stay well.

Cynthia

TO: NBCC Board, Field Coordinators, National Action Network

FROM: Fran Visco

RE: FINAL DOD BCRP PUSH IN THE HOUSE/Senate Letter Now Circulating!

URGENT ALERT!! URGENT ALERT!! URGENT ALERT!! URGENT ALERT!!

Monday, March 13th is the final day to get Representatives signed onto the House DOD Letter in support of $150 million for the Department of Defense (DOD) Peer-Reviewed Breast Cancer Research Program (BCRP). With 129 current signers, that gives us ONLY 3 BUSINESS DAYS to get at least 98 more Representatives to agree to sign on!

Yesterday, Senators Snowe, Leahy, Specter, Harkin, and Collins began circulating the Dear Colleague Letter asking Senators to sign a letter to Chairman Stevens and Ranking Member Inouye of the Defense Appropriations Subcommittee calling for $150 million for the DOD BCRP. The date the Senate letter is due is not yet determined.

We need you and your network to take immediate action and 1) first keep pressing your Representatives who have not yet signed the House letter, and then, 2) move on to your Senators to sign the Senate letter! We need to at least match the 227 Representatives and 62 Senators that we secured last year!

Below is a listing by state of the Representatives who have signed on to date. Remember, signing this letter is the way your Representatives and Senators can show their support for the DOD BCRP and get credit in NBCC's voting record.

Again, we have only 3 business days left to get 98 more House signers so please make your calls TODAY! The phone and fax numbers for all Members of the 109th Congress can be found on our website at www.stopbreastcancer.org by clicking on "Public Policy Activities" and then "Members of Congress" on the dropdown menu.Your message is:

House Message:
I urge you to show your support for ending breast cancer by signing the letter to the Military Quality of Life Appropriations Subcommittee calling for $150 million for the Department of Defense Peer-Reviewed Breast Cancer Research Program for FY 2007!!

Senate Message:
I urge you to show your support for ending breast cancer by signing the letter to the Defense Appropriations Subcommittee calling for $150 million for the Department of Defense Peer-Reviewed Breast Cancer Research Program for FY 2007!!

If your Representative agrees to sign the letter, her/his staff should EMAIL one of the following letter sponsors' staff to make it happen:
Jean Doyle (Rep. Lowey) at jean.doyle@mail.house.gov
Darcie Brickner (Rep. T. Davis) at darcie.brickner@mail.house.gov
Brian Petersen (Rep. Biggert) at brian.petersen@mail.house.gov
Rianna Brown (Rep. McGovern) at rianna.brown@mail.house.gov

If your Senator agrees to sign the letter, HER/HIS STAFF SHOULD CALL one of the following letter sponsors' staff to make it happen:
Michelle Stefanick (Sen. Snowe) at (202) 224-5344
Daniel Ginsberg (Sen. Leahy) at (202) 224-4242
Chris Bradish (Sen. Specter) at (202) 224-4254
Jenelle Krishnamoorthy (Sen. Harkin) at (202) 224-3254
Priscilla Hanley (Sen. Collins) at (202) 224-2523

Please call D'Neisha Simmons Jendayi at (800) 622.2838, ext. 579 or email her at dsjendayi@stopbreastcancer.org to let her know that your Member has agreed to sign onto the letter, if you have questions, or if you need to have copies of any of the attachments (listed below) faxed to help you get the job done.

Thank you for your urgent advocacy as we work to preserve this critically important program!

Attachments:
1) List of last year's House letter signers that haven't signed on yet this year . . . they all should be willing to sign on again!
2) Letter to the House Military Quality of Life Appropriations Subcommittee
3) House Dear Colleague Letter
4) Letter to the Senate Defense Appropriations Subcommittee
5) Senate Dear Colleague Letter


FY07 DOD BCRP House of Representatives Letter Signers
129 signers as of 3/7/06. * indicates member did not sign letter last year

ALABAMA

ALASKA
Don Young (R)

ARIZONA
Rep. J.D. Hayworth (R-5th)
Rep. Raul Grijalva (D-7th)

CALIFORNIA
Rep. Mike Thompson (D-1st)
Rep. Doris O. Matsui (D-5th)
Rep. George Miller (D-7th)
Rep. Ellen Tauscher (D-10th)
Rep. Tom Lantos (D-12th)
Rep. Fortney Pete Stark (D-13th)
Rep. Anna Eshoo (D-14th)
Rep. Michael M. Honda (D-15th)
Rep. Sam Farr (D-17th)
Rep. Dennis Cardoza (D-18th)
Rep. Lois Capps (D-23rd)
Rep. Brad Sherman (D-27th)
Rep. Howard L. Berman (D-28th)
Rep. Adam Schiff (D-29th)
Rep. Henry Waxman (D-30th)
Rep. Hilda Solis (D-32nd)
Rep. Jane Harman (D-36th)
Rep. Jaunita Millender-McDonald (D-37th)
Rep. Linda T. Sanchez (D-39th)

COLORADO

CONNECTICUT
Rep. John Larson (D-1st)
Rep. Rosa DeLauro (D-3rd)
Rep. Christopher Shays (R-4th)

DELAWARE

FLORIDA
Rep. Mark Foley (R-16th)*
Rep. Ileana Ros-Lehtinen (R-18th)
Rep. Robert Wexler (D-19th)
Rep. Debbie Wasserman Schultz (D-20th)*

GEORGIA
Rep. Jim Marshall (D-3rd)
Rep. John Lewis (D-5th)
Rep. Charles Norwood (R-9th)

HAWAII
Rep. Ed Case (D-2nd)

ILLINOIS
Rep. Luis Gutierrez (D-4th)
Rep. Rahm Emanuel (D-5th)
Rep. Danny K. Davis (D-7th)
Rep. Melissa L. Bean (D-8th)
Rep. Janice D. Schakowsky (D-9th)
Rep. Judy Biggert (R-13th) Sponsor
Rep. Donald Manzullo (R-16th)

INDIANA
Rep. Dan Burton (R-5th)

IOWA
Rep. Jim Nussle (R-1st)
Rep. Jim Leach (R- 2nd)
Rep. Leonard Boswell (D-3rd)
Rep. Tom Latham (R-4th)
Rep. Steve King (R-5th)

KANSAS

KENTUCKY

LOUISIANA
Rep. William J. Jefferson (D-2nd)
Rep. Richard H. Baker (R-6th)

MAINE
Rep. Thomas H. Allen (D-1st)
Rep. Michael H. Michaud (D-2nd)

MARYLAND
Rep. Benjamin L. Cardin (D-3rd)
Rep. Elijah Cummings (D-7th)
Rep. Chris Van Hollen (D-8th)

MASSACHUSETTS
Rep. John W. Olver (D-1st)
Rep. James McGovern (D-3rd) Sponsor
Rep. Barney Frank (D-4th)
Rep. John F. Tierney (D-6th)
Rep. Edward Markey (D-7th)
Rep. Michael Capuano (D-8th)
Rep. Stephen F. Lynch (D-9th)
Rep. William Delahunt (D-10th)

MICHIGAN
Rep. Dale Kildee (D-5th)
Rep. Sander Levin (D-12th)
Rep. John Conyers (D-14th)*
Rep. John Dingell (D-15th)

MINNESOTA
Rep. Betty McCollum (D-4th)

MISSISSIPPI

MISSOURI
Rep. William Lacy Clay (D-1st)
Rep. Ike Skelton (D-4th)*
Rep. Emanuel Cleaver (D-5th)

NEBRASKA
Rep. Lee Terry (R-2nd)

NEVADA

NEW HAMPSHIRE
Rep. Charles Bass (R-2nd)

NEW JERSEY
Rep. Frank A. LoBiondo (R-2nd)
Rep. Scott Garrett (R-5th)
Rep. Frank Pallone Jr. (D-6th)
Rep. Steve Rothman (D-9th)*
Rep. Donald M. Payne (D -10th)

NEW MEXICO
Rep. Tom Udall (D-3rd)

NEW YORK
Rep. Tim Bishop (D-1st)
Rep. Steve J. Israel (D-2nd)
Rep. Carolyn McCarthy (D-4th)
Rep. Gary Ackerman (D-5th)
Rep. George W. Meeks (D-6th)
Rep. Joseph Crowley (D-7th)
Rep. Jerrold Nadler (D-8th)
Rep. Major R. Owens (D-11th)
Rep. Carolyn Maloney (D-14th)
Rep. Charles B. Rangel (D-15th)
Rep. Nita M. Lowey (D-18th) Sponsor
Rep. Michael McNulty (D-21st)
Rep. Maurice Hinchey (D-22nd)
Rep. Louise McIntosh Slaughter (D-28th)
Rep. John Randy Kuhl (R-29th)

NORTH CAROLINA
Rep. Howard Coble (R-6th)
Rep. Mike McIntyre (D-7th)

OHIO
Rep. Dennis J. Kucinich (D-10th)
Rep. Sherrod Brown (D-13th)
Rep. Tim Ryan (D-17th)*

OREGON
Rep. Peter A. DeFazio (D-4th)
Rep. Darlene Hooley (D-5th)

PENNSYLVANIA
Rep. Robert Brady (D- 1st)
Rep. Philip S. English (R-3rd)
Rep. Michael Fitzpatrick (R-8th)*
Rep. Alyson Schwartz (D-13th)
Rep. Tim Holden (D-17th)
Rep. Todd R. Platts (R-19th)

RHODE ISLAND
Rep. Patrick J. Kennedy (D-1st)
Rep. James Langevin (D-2nd)

SOUTH CAROLINA

SOUTH DAKOTA

TENNESSEE

TEXAS
Rep. Ralph Hall (R-4th)*
Rep. Ron E. Paul (R-14th)
Rep. Silvestre Reyes (D-16th)*
Rep. Charles Gonzalez (D-20th)
Rep. Henry Bonilla (R-23rd)
Rep. Lloyd Doggett (D-25th)
Rep. Gene Green (D-29th)
Rep. Eddie Bernice Johnson (D-30th)*

UTAH

VERMONT
Rep. Bernard Sanders (I-1st)

VIRGINIA
Rep. Bobby Scott (D-3rd)
Rep. Eric I. Cantor (R-7th)
Rep. James P. Moran (D-8th)
Rep. Rick Boucher (D-9th)
Rep. Frank R. Wolf (R-10th)
Rep. Thomas M. Davis (R-11th) Sponsor

WASHINGTON
Rep. Jay Inslee (D-1st)

WEST VIRGINIA
Rep. Shelley Moore Capito (R-2nd)*

WISCONSIN
Rep. Tammy Baldwin (D-2nd)
Rep. Ron Kind (D-3rd)
Rep. Gwen Moore (D-4th)

DISTRICT OF COLUMBIA
Del. Eleanor Holmes Norton (D)

GUAM
Madeleine Bordallo (D)

[uma]

There is no such thing as a Herceptin Vaccine. Herceptin is a monoclonal antibody. The title is misleading, it must be a Her2 Vaccine.

[karenann]

It is not a Herceptin vaccine, it is a vaccine for women who are Her2 positive. If you read the article, it will explain. Oh, and people from this site have participated.

Karen

[julierene]

I tried changing the title, it doesn't seem to want to work. Herceptin and HER2 kinda run together in my mind... Sorry about that!

[Barbara2]

Cynthia, I will be finishing "late herceptin" in June, and would love to know if any Her2 vaccine trials have been set up for us. I was one node positive.

Please let me know how I can help in the search for trial information.

Thanks for your time,

Barbara

[Cynthia]

Barbara,

I don't know the status of approving the Walter Reed/Windber E75 breast cancer vaccine trial for folks who have taken Herceptin, but I will inquire and let you know what I find out.

Stay well.

Cynthia

[Lauriemn]

Barbara, I just received material about joining this trial and I am also finishing Herceptin soon. The nurse told me you can start the trial as soon as you finish Herceptin.

Cynthia, I posted a question for you on the trials page, but will ask it here also. I am in Minnesota and would have to go to Penn. for the trial. I thought I could fly in and out the same day, but as I was reading through the material, they refer to being checked 48 hours after receiving the vaccine. Is that every time or just the first time? Also, did you have any side effects?

Thanks, Laurie

[Cynthia]

Barbara,
I just heard from the vaccine nurse at Walter Reed regarding eligibility for the E75 breast cancer vaccine trial. (Windber is doing the civilian side of this trial.) Woman who had been on Herceptin were previously excluded. I recently inquired to see if that has changed. It looks like it has; here is what she said:

It is okay if you have had Herceptin or are soon to finish. But if you are currently on Herceptin you need to wait until your treatment is complete.

Laurie,

You do need to be checked 48 hours after each injection so they can measure the skin response to the injection. It is a pain and was easier for me because I am local and could drive the hour back and forth rather easily. I understand that those who fly in for the injection tend to hang around the required 48 hour period and then fly home. Other than itchy skin, I had no adverse side effects at all.

I wish you both the best.

Cynthia

Cynthia