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Vaccine Therapy and Trastuzumab With or Without Polysaccharide-K (PSK®) in Treating Patients With Stage IV HER2 Positive Breast Cancer

Complete title: Phase I/II Randomized Study of Combination Immunotherapy With or Without Polysaccharide Krestin (PSK®) Concurrently with a HER2 ICD Peptide-Based Vaccine in Patients with Stage IV Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

Research Study Number       7866
Principal Investigator       Lupe Salazar, MD
Phase       I/II

Look up trial at NIH

Research Study Description

This randomized phase I/II trial studies the side effects of vaccine therapy and trastuzumab with or without polysaccharide-K (PSK®) and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PSK® may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy and trastuzumab is more effective when given with or without PSK® in treating breast cancer.

Eligibility Criteria (must meet the following to participate in this study)

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

- Patients with stage IV HER2+ breast cancer treated to:

- * No evidence of disease (NED), or

- * Stable bone only disease after definitive therapy

- HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in the primary tumor or metastasis; or documented gene amplification by fluorescent in situ hybridization (FISH) analysis; IHC =< 2+ must have HER2 gene amplification documented by FISH

- Patients must continue trastuzumab monotherapy dosing per standard of care through the vaccine portion of the study

- Patients must be at least 21 days post cytotoxic chemotherapy prior to enrollment

- Patients must be at least 14 days post systemic steroids prior to enrollment

- Patients must be at least 28 days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)

- Patients on bisphosphonates and/or endocrine therapy are eligible

- Men and women of reproductive ability must agree to contraceptive use during entire study period

- Patients must have Zubrod performance status score of =< 2

- Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have significant active concurrent medical illnesses precluding study treatment

- White blood cell (WBC) >= 3000/mm^3

- Hemoglobin (Hgb) >= 10 mg/dl

- Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min

- Total bilirubin =< 1.5 mg/dl

- Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times the upper limit of normal

- Patients must have adequate cardiac function as demonstrated by normal left ventricular ejection fraction (LVEF) on multi gated acquisition (MUGA) scan or echocardiogram performed within 3 months of enrollment

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Patients with any of the following cardiac conditions:

- * Restrictive cardiomyopathy

- * Unstable angina within 6 months prior to enrollment

- * New York Heart Association functional class III-IV heart failure

- * Symptomatic pericardial effusion

- Patients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based products

- Patients with any clinically significant autoimmune disease requiring active treatment

- Patients receiving any concurrent immunomodulators

- Patients who are pregnant or breast-feeding

- Patients who are simultaneously enrolled in other treatment studies

- Patients who have received a previous HER2 breast cancer vaccine

- Known hypersensitivity reaction to mushroom products

Other exclusion criteria may apply.

Research Study Number       7866
Contact       Jennifer Childs
Telephone       (206) 616-2305

Breast Cancer; Solid Tumors

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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