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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01922921
First received: August 1, 2013
Last updated: June 26, 2014
Last verified: June 2014

August 1, 2013
June 26, 2014
February 2014
September 2015   (final data collection date for primary outcome measure)
Incidence of grade 3 or higher toxicity (including systemic and local injection site reactions) graded per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) 4.0 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Evaluated using physical examination and clinical labs. Type and grade of toxicities noted during treatment will be summarized.
Safety and systemic toxicity graded per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) 4.0 [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Evaluated using physical examination and clinical labs. Type and grade of toxicities noted during treatment will be summarized.
Complete list of historical versions of study NCT01922921 on ClinicalTrials.gov Archive Site
Induction of IFN-gamma production and CD107a expression in NK cells, via flow cytometry [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
Augmentation of NK cell activity is defined by a 2-fold increase in NK cell IFN-gamma production and CD107a expression from baseline after 4 weeks of oral administration of polysaccharide-K.
Same as current
  • Change in pro-inflammatory serum cytokine and/or chemokines assessed by Luminex analysis [ Time Frame: Baseline to 24 hours after completion of treatment ] [ Designated as safety issue: No ]
  • Change in intermolecular epitope spreading assessed by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISPOT) assay [ Time Frame: Baseline to 12 months after completion of treatment ] [ Designated as safety issue: No ]
  • Change in serum TGF-beta levels assessed by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Baseline to 12 months after completion of treatment ] [ Designated as safety issue: No ]
  • PFS [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • OS [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Not Provided
 
Vaccine Therapy and Trastuzumab With or Without Polysaccharide-K in Treating Patients With Stage IV HER2 Positive Breast Cancer
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

This randomized phase I/II trial studies the side effects of vaccine therapy and trastuzumab 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. 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. Polysaccharide-K 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 polysaccharide-K in treating breast cancer.

PRIMARY OBJECTIVES:

I. To evaluate the safety of polysaccharide-K (PSK) when given with a HER2 ICD peptide-based vaccine and trastuzumab.

SECONDARY OBJECTIVES:

I. To evaluate the effect of PSK on natural killer (NK) cell functional activity when given with a HER2 ICD peptide-based vaccine and trastuzumab.

TERTIARY OBJECTIVES:

I. To investigate the effect of PSK when given with a HER2 ICD peptide-based vaccine and trastuzumab on: serum levels of pro-inflammatory cytokine and/or chemokines; intermolecular epitope spreading; serum transforming growth factor (TGF)-beta levels; progression free survival (PFS) and overall survival (OS).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive HER2 ICD peptide-based vaccine intradermally (ID) once monthly for 3 months, trastuzumab per standard of care, and placebo orally (PO) twice daily (BID) for 4 months.

ARM II: Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab as in Arm I and polysaccharide-K PO BID for 4 months.

After completion of study treatment, patients are followed up for 8 months, and then twice annually for 3 years.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HER2-positive Breast Cancer
  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Biological: HER-2/neu intracellular domain protein
    Given ID
    Other Names:
    • HER-2 ICD Peptide
    • HER-2/neu ICD Protein
  • Biological: trastuzumab
    Given per standard of care
    Other Names:
    • anti-c-erB-2
    • Herceptin
    • MOAB HER2
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Biological: polysaccharide-K
    Given PO
    Other Names:
    • Krestin
    • PSK
  • Other: laboratory biomarker analysis
    Correlative studies
  • Active Comparator: Arm I (placebo)
    Patients receive HER2 ICD peptide-based vaccine ID once monthly for 3 months, trastuzumab per standard of care, and placebo PO BID for 4 months.
    Interventions:
    • Biological: HER-2/neu intracellular domain protein
    • Biological: trastuzumab
    • Other: placebo
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (polysaccharide-K)
    Patients receive HER2 ICD peptide-based vaccine ID and trastuzumab as in Arm I and polysaccharide-K PO BID for 4 months.
    Interventions:
    • Biological: HER-2/neu intracellular domain protein
    • Biological: trastuzumab
    • Biological: polysaccharide-K
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
United States
 
NCT01922921
7866, NCI-2013-01377, 135, 7866, U19AT006028, P30CA015704
No
University of Washington
University of Washington
  • National Cancer Institute (NCI)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Lupe Salazar Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP