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

Complete title: Phase I-II Study of HER2 Vaccination with poly(I)* poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients

Research Study Number       7425
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 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. Our group has developed vaccines against the HER2 protein that create immune responses and in this study we are researching different ways that we may be able to make that immune response even better. Adjuvants are one way to help vaccines produce stronger immune responses. Our group has typically used the adjuvant GM-CSF and in this study we would like to look at another adjuvant called rintatolimod. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be an effective treatment for 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

Inclusion Criteria:

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

Exclusion Criteria:

- 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 the last 30 days

- 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

Other exclusion criteria may apply.

Research Study Number       7425
Contact       Tumor Vaccine Group, Study Line
Telephone       206/543-6620

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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