Clinical trial · Interventional
Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer
Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu peptide vaccine | Biological | — | UNRESOLVED |
| rintatolimod | Drug | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Stage I, Arm 1 (HER-2/neu peptide vaccine and rintatolimod)
- description
- Arm 1: HER2 peptide vaccine + 4 mcg Ampligen® Five groups of randomized patients with each group receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses).
- interventionNames
- Biological: HER-2/neu peptide vaccine
- Drug: rintatolimod
- type
- ACTIVE_COMPARATOR
- label
- Stage II, Arm I (HER-2/neu peptide vaccine and sargramostim)
- description
- Patients receive synthetic HER-2/neu peptide vaccine admixed with GM-CSF ID.
- interventionNames
- Biological: HER-2/neu peptide vaccine
- Biological: sargramostim
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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 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
References
Publications (0)
Data not yet available