Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer

Completed · Phase 1/Phase 2

Conditions studied: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

In brief

This randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies, such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary treatment to lower the risk that the cancer will come back and are one way to help vaccines produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be a safe and effective treatment for breast cancer.

Key facts

Study ID

NCT01355393

Run by

University of Washington

People needed

50

Starts

2011-07-01

Last updated by the study team

2020-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with stage II, or III HER2+ breast cancer who have completed definitive standard treatment and are in complete remission - or -
• Patients with stage IV HER2+ breast cancer treated to:
• No evidence of disease, or
• Stable bone only disease after definitive therapy
• Patients must have demonstrated HER2 positive disease, by one of the following methods:
• Immunohistochemical (IHC) staining of 1+, 2+ or 3+ for the HER2 protein, or
• Amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
• Patients must be at least 14 days post cytotoxic chemotherapy prior to enrollment
• Patients must be at least 14 days post systemic steroids prior to enrollment
• Patients on bisphosphonates or continued hormone therapy are eligible
• Men and women of reproductive ability 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 any significant active concurrent medical illnesses precluding protocol treatment
• White blood cell count (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 on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fractions (EF) on multi gated acquisition scan (MUGA) scan or echocardiogram performed within the last 3 months of eligibility sign off

You may not qualify if…

• 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 rhuGM-CSF based products
• Patients with any clinically significant autoimmune disease requiring active treatment
• Patients receiving any concurrent immunomodulators within 30 days of eligibility sign-off
• Patients who are pregnant or breast-feeding
• Patients who are simultaneously enrolled in any other treatment study
• Patients who have received a previous HER2 breast cancer vaccine

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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