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Vaccine Therapy With or Without Polysaccharide-K in Treating Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy

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

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Research Study Description

This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy works better when given with or without polysaccharide-K in treating breast cancer.

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

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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 HER2-targeted monoclonal antibody therapy dosing per standard of care through the entire study period (one year)

-- * HER2-targeted monoclonal antibody therapy is defined as either trastuzumab monotherapy, or trastuzumab and pertuzumab combination therapy administered per standard of care

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

- Patients must be at least 28 days post immunosuppressants 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

- Patients who are having sex that could lead to pregnancy must agree to contraceptive use during the 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) >= the lower limit of normal for the facility on multi gated acquisition (MUGA) scan or echocardiogram (ECHO) 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 immunosuppressants

- 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

- Patients that have ever had a life-threatening allergic reaction after a dose of any tetanus or diphtheria containing vaccine, OR have had a severe allergy to any part of a tetanus or diphtheria vaccine

- Patients with epilepsy or another nervous system problem, severe pain or swelling after any vaccine containing diphtheria or tetanus; or ever had Guillain Barré syndrome (GBS)

- Known hypersensitivity reaction to mushroom products

Other exclusion criteria may apply.



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

Keywords
Breast Cancer; Solid Tumors; HER2-Positive

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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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