[jacqueline1102]

Hi Karen,

Thought you might be interested in this one. I think Steph might have done this one. Jessica is the person heading up the research participants. You can stay on herceptin during this trial, as well, which is good thing.

Take care,

Jackie

Breast Cancer

Protocol 135: Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently with a HER2 ICD Peptide-Based Vaccine and Trastuzumab in Patients with Stage IV Breast Cancer
Patient Population

Patients with Stage IV breast cancer treated to:
Complete remission, or
Stable bone only disease after finishing treatment
Breast cancer must be HER2+
Patients are expected to be on Trastuzumab (Herceptin) during the entire study period (one year)
Patients must be off chemotherapy for 21 days before the enrolling into the study
Patients must be off steroids for 14 days before enrolling into the study
Patients must be off any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake,) for 28 days before joining the study and agree to withhold them for the entire study period (one year)
Patients may be taking bisphosphonates (examples: Zoledronic acid (Zometa), Alendronate sodium (Fosamax), Ibandronate (Boniva)) and/or endocrine (examples: Anastrazole (Arimidex), Exemestane (Aromasin), Fulvestrant (Faslodex)) therapy
Men and women must agree to use birth control if needed during the entire study period (one year)
Patients must be at least 18 years of age
Number of Patients 30

Study Objectives

To look at how safe PSK® (a natural mushroom product) is when given with HER2 peptide-based vaccine and Herceptin
To look at the effect of PSK® on the immune system when given with a HER2 peptide based vaccine and Herceptin
Treatment Information

Eligible patients will randomly assigned to one of two treatment groups (15 patients per group):

Arm 1: HER2 vaccine + *Herceptin + Placebo tea
Arm 2: HER2 vaccine + *Herceptin + PSK® tea
Patients and the study team will not be told which arm a patient is assigned to

*Patients will need to remain on their current regimen of Herceptin with their primary oncologist; this will not be provided by the study

On-Site Study Visits

HER2 peptide vaccines will be given monthly for 3 months
Receive monthly supply of tea (PSK® or placebo) at each visit for 4 months
Follow-up visit: 1 month after last vaccine
Long-term Follow-up

Follow-up research blood draws: 2 months and 9 months after the last vaccine - may be done at patient’s oncologist’s office
Information on how the patient is doing will be obtained from patient’s primary oncologist twice a year for up to three years
Total Visits

5 visits at the University of Washington Medical Center-Clinical Research Center
Other Procedures During Study Visits

History and physicals
Tetanus vaccine at first visit only
Monthly pregnancy test if needed
Clinical blood tests plus research blood to do immune monitoring
Study Location:

University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195

Related Publications

Generation of T-cell immunity to the HER-2/neu protein after active immunization with HER-2/neu peptide-based vaccines.

Disis ML, Gooley TA, Rinn K, Davis D, Piepkorn M, Cheever MA, Knutson KL, Schiffman J Clin Oncol. 2002 June

1;20(11):2624-32.

ClinicalTrials.gov Identifier: NCT01922921

Clinical Trials Contact
For more information regarding our trials, please call our Patient Coordinator

Doreen Higgins
866-932-8588
Email