Vaccine Therapy and Cyclophosphamide in Treating Patients With Stage II-III Breast or Stage II-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Phase 1

Completed

• Conditions: Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Stage IIA Breast Cancer; Stage IIA Fallopian Tube Cancer; Stage IIA Ovarian Cancer; Stage IIB Breast Cancer; Stage IIB Fallopian Tube Cancer; Stage IIB Ovarian Cancer

• Registration Number: NCT01606241
• Lead Sponsor: Mayo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-5-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Inclusion Criteria:<br><br> - Clinically confirmed no evidence of disease >= 90 days from completion of systemic<br> therapy with the exception of hormonal therapy and bisphosphonates (per practice<br> guidelines for breast and ovarian cancer)<br><br> - Histological or cytological confirmation of stage II or III breast cancer or stage<br> II, III, or IV ovarian/primary peritoneal/fallopian tube cancer; Note: patients with<br> stage IV ovarian/primary peritoneal/fallopian tube cancer must register within one<br> year of completing chemotherapy<br><br> - Completed systemic treatment (chemotherapy, immune modulators [such as trastuzumab],<br> radiation, and/or corticosteroids) with the exception of hormonal therapy and<br> bisphosphonates >= 90 days prior to registration<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1<br><br> - Absolute neutrophil count (ANC) >= 1500/mm^3<br><br> - Platelets >= 100,000/ul<br><br> - Hemoglobin >= 10.0 g/dL<br><br> - Creatinine =< 1.5 x upper limit of normal (ULN) or 24 hour urine =< grade 2<br><br> - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =<<br> 3 x ULN<br><br> - Serum albumin >= 3 g/dL<br><br> - Urinalysis with =< 2+ proteinuria<br><br> - Thyroid-stimulating hormone (TSH) - negative or =< normal institutional range<br><br> - Anti-nuclear antibody (ANA) - negative or =< normal institutional range<br><br> - Serum rheumatoid factor (RF) - negative or =< normal institutional range<br><br> - Negative serum pregnancy test done =< 7 days prior to registration, for women of<br> childbearing potential only<br><br> - Capable of understanding the investigative nature, potential risks, and benefits of<br> the study and capable of providing valid informed consent<br><br> - Willing to return to Mayo Clinic Rochester for follow-ups (immunizations, blood<br> draws, etc.)<br><br> - Willing to provide mandatory blood samples for primary and correlative goals<br><br> - Willing to receive a tetanus vaccination if you have not had one within the past<br> year<br><br>Exclusion Criteria:<br><br> - Any of the following:<br><br> - Pregnant women<br><br> - Nursing women unwilling to stop breast feeding<br><br> - Men or women of childbearing potential who are unwilling to employ adequate<br> contraception from the time of registration through cycle 6 (or the final<br> vaccine cycle for each patient)<br><br> - Co-morbid systemic illnesses or other severe concurrent disease which, in the<br> judgment of the investigator, would make the patient inappropriate for entry into<br> this study or interfere significantly with the proper assessment of safety and<br> toxicity of the prescribed regimens<br><br> - Immunocompromised patients (other than that related to the use of corticosteroids)<br> including patients known to be human immunodeficiency virus (HIV) positive<br><br> - Uncontrolled intercurrent illness including, but not limited to, ongoing or active<br> infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac<br> arrhythmia, or psychiatric illness/social situations that would limit compliance<br> with study requirements<br><br> - Receiving any other investigational agent<br><br> - Other active malignancy =< 5 years prior to registration; EXCEPTIONS: Non-melanoma<br> skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history of prior<br> malignancy, they must not be receiving other specific treatment (cytotoxics,<br> monoclonal antibodies, small molecule inhibitors) for this cancer<br><br> - Known history of autoimmune disease<br><br> - Any contraindication to receiving sargramostim (GM-CSF) or cyclophosphamide<br><br> - Uncontrolled acute or chronic medical conditions including, but not limited to the<br> following:<br><br> - Active infection requiring antibiotics<br><br> - Congestive heart failure (New York Heart Association class III or IV; moderate<br> to severe objective evidence of cardiovascular disease)<br><br> - Myocardial infarction or stroke within previous 6 months<br><br> - Use of a systemic steroid =< 30 days prior to registration<br><br> - Receiving thyroid replacement therapy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who experience severe toxicities (grades 3-5 of the National Cancer Institute's Cancer Therapy Evaluation Program [CTEP] Common Terminology Criteria for Adverse Events, version 4.0)

Secondary Outcome Measures

Name	Time	Method
Disease-free survival;FRa expression;Overall survival time;Percentage change in plasma concentration of cytokines and chemokines