Clinical trial NCT03066947 (phase 1/phase 2, status: completed)
Conditions: breastcancer, breast neoplasm
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  1. Have histological confirmation of breast cancer with recurrent and/or metastatic
             lesions via investigational site.

               -  Patients with new or progressive breast cancer metastatic to brain will be
                  eligible provided:

                    1. There is no need for steroids and patients have not had steroids at least 2
                       weeks

                    2. No individual tumor size is >50 mm3

                    3. ECOG status <3

                    4. Tumor is not impinging on Middle Cerebral Artery/speech-motor strip

                    5. If surgically debulked, must be healed from surgery and at least 3 weeks
                       have elapsed since general anesthesia

                    6. Patients consent to MRI studies at 3-4 week intervals until evidence of
                       tumor regression on at least 2 imaging studies. In no case, will the
                       interval between MRI studies be longer than 3 months. MRI study may be
                       introduced at any time should the patients develop new or clearly worsening
                       symptoms and/or introduction of steroids

                       2. Have evidence of persistent, recurrent, or progressive disease for which
                       there is no known or established treatment available with curative intent,
                       after failing at least one course of community standard systemic treatment
                       with chemotherapy (and endocrine therapy if appropriate)

                       3. Be 18 years of age or older and female

                       4. Have expected survival of at least 4 months

                       5. Have adequate performance status (ECOG 0-2)

                       6. Patients may be maintained on hormonal therapy provided there is clear
                       evidence of tumor progression

                       7. Have provided written informed consent.

                       Exclusion Criteria:

               1. Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have
                  had immunotherapy in the past (off within 3 weeks), or general anesthesia/major
                  surgery (within 3 weeks). Patients must have recovered from all known or expected
                  toxicities from previous treatment and passed a treatment-free "washout" period
                  of 3 weeks before starting this program (8 weeks for persons receiving
                  nitrosourea or mitomycin).

               2. History of clinical hypersensitivity to GM-CSF, Interferon-alpha-2b (Merck),
                  yeast, beef, or to any components used in the preparation of the experimental
                  vaccine.

               3. BUN >30 and a creatinine >2.

               4. Absolute granulocyte count < 1000; platelets <100,000.

               5. Bilirubin >2.0; alkaline phosphatase >5x upper limit of normal (ULN); ALT/AST >2x
                  ULN.

               6. Proteinuria >1+ on urinalysis or >1 gm/24hr.

               7. Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA
                  scan) below the normal limits of the institutions specific testing range. This
                  assessment may be repeated once at the discretion of the Investigator with the
                  approval of the Sponsor.

               8. New York Heart Association stage 3 or 4 cardiac disease.

               9. A pleural effusion of moderate severity or worse.

              10. Any woman of childbearing potential, unless she:

                    1. Agrees to take measures to avoid becoming pregnant during the study and

                    2. Has a negative serum pregnancy test within 7 days prior to starting
                       treatment.

              11. Women who are pregnant or nursing.

              12. Patients with concurrent second malignancy. Persons with previous malignancies
                  effectively treated and not requiring treatment for >24 months are eligible,
                  provided there is unambiguous documentation that current local recurrence or
                  metastatic site represents recurrence of the primary breast malignancy.

              13. Patients who are HIV positive (by self-report) or have clinical or laboratory
                  features indicative of AIDS.

              14. 14. Patients who require systemic steroids at a dose equivalent of >10 mg/day of
                  prednisone. Beta-blocker therapy, while not exclusionary, is discouraged and
                  alternatives should be sought if possible. The beta-blocker might compromise use
                  of epinephrine for the rare possibility of anaphylaxis. Anticoagulants must be
                  approved by the Investigator with notification of the Sponsor.

              15. Patients who are on treatment for rheumatological or autoimmune disease unless
                  approved by the Investigator in consultation with the Sponsor (e.g., as for
                  replacement therapy for autoimmune thyroiditis or diabetes).

              16. Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline
                  personality disorder) or other clinically progressive major medical problems,
                  unless approved by the PI.

              17. Male breast cancer patients.

              18. Patients may not be on a concurrent clinical trial, unless approved by PI.