Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT01522820
Eligibility Criteria:
Inclusion Criteria:
* Patients with any solid tumors at high risk of recurrence or with minimal residual disease; there may or may not be measurable or symptomatic disease (i.e., patients with bladder, brain, breast, esophageal, gastrointestinal, hepatocellular, kidney, lungs, melanoma, ovarian, prostate, sarcomas, and uterine)
* Cancer types:
* Prostate cancer: patients with metastatic, castrate refractory prostate cancer; the use of luteinizing hormone-releasing hormone (LHRH) agonist is allowed
* Kidney cancer: patients with metastatic kidney cancer; prior therapies with cytokines, vascular endothelial growth factor (VEGF) and mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors are allowed
* Bladder cancer: patients with metastatic urothelial carcinoma; prior cisplatin-based therapies are allowed
* Ovarian cancer: eligible patients may have asymptomatic residual measurable disease on physical examination and/or computed tomography (CT) scan, and/or may have an elevated cancer antigen (CA)-125; or may be in complete clinical remission after treatment for primary or recurrent disease
* Brain tumors: histologic proof of one of the following: glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic mixed glioma or anaplastic oligoastrocytoma; patients who have had recent cranial surgery are eligible for inclusion, but the vaccine may not be administered prior to postoperative day 14
* Uterine cancer: patients with advanced (stages II-IV) or recurrent disease who have completed standard therapy, currently no evidence of disease (NED) or with minimal residual disease; patients with stage I uterine serous carcinomas or sarcomas are also eligible after completion of standard therapy
* Breast cancer: patients can enter study after completion of all chemotherapy (including trastuzumab), radiation, and breast/axillary surgery; patients may participate while on endocrine therapy; stages I-III patients with the following characteristics:
* Estrogen-receptor (ER) negative with positive lymph nodes; ER negative with negative nodes if tumor \> 2 cm; ER positive with positive lymph nodes; and ER positive with negative lymph nodes and tumor \> 5 cm
* Sarcomas: patients with sarcomas of any site, who have completed standard therapy, and are in remission, or have minimal disease burden
* Lungs: resected patients with hilar or ipsilateral mediastinal nodal disease (i.e., a subset of patients with stage II and IIIA disease); and patients with residual disease on imaging after definitive radiation or chemoradiation therapy
* Esophageal: resected patients with any nodal (i.e., thoracic or abdominal) disease; and patients with residual disease on imaging after definitive chemoradiation therapy
* Melanoma: stage IIB, stage IIC, and stage III who have completed planned definitive therapy for their disease including radiotherapy and/or interferon; patients declining interferon or with contra-indications to interferon will also be eligible provided they meet requisite criteria for this study (i.e., non-measurable disease); stage IV melanoma of M1a sub-type only, who are not candidates for additional therapy of curative potential (i.e., small volume disease; may be measurable or evaluable); and stage IV melanoma, NED, status post (s/p) complete resection of known sites of disease (i.e., non-measurable disease)
* Hepatocellular carcinoma (HCC): patients who have been treated with surgical resection for HCC; and following chemoembolization as adjuvant therapy for HCC
* Gastrointestinal: patients who have completed standard therapies for gastric and colorectal cancers, and deemed to be at high-risk of relapse
* Any human leukocyte antigen (HLA) type; historic HLA typing is permitted
* Tumor expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) and/or reverse transcription polymerase chain reaction (RTPCR)
* Life expectancy \> 6 months
* Absolute neutrophil count (ANC) \>= 1,000/uL
* Platelets (PLT) \>= 75,000/uL
* Hemoglobin (Hgb) \>= 8 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Serum aspartate aminotransferase (serum glutamic oxaloacetic transaminase \[SGOT\]/aspartate aminotransferase \[AST\]) or serum alanine aminotransferase (serum glutamate pyruvate transaminase \[SGPT\]/alanine aminotransferase \[ALT\]) =\< 3 x ULN
* Serum creatinine =\< 2 x ULN
* Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x ULN; patients receiving anticoagulation therapy, PT/INR =\< 3
* Pulmonary function tests: forced expiratory volume in one second (FEV1) \> 50% and diffusion capacity of the lungs for carbon monoxide (DLCO) \> 50%
* Pulse oximetry: oxygen (O2) saturation \>= 90% on room air
* Electrocardiogram, showing no clinical significant or acute abnormality
* Have been informed of other treatment options
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
Exclusion Criteria:
* Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
* History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
* Concomitant systemic treatment with corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, aspirin \> 325 mg; specific cyclooxygenase (COX)-2 inhibitors are permitted
* Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study agent (6 weeks for nitrosoureas); concomitant hormonal therapies for breast and prostate cancers are allowed
* Clinically significant heart disease (New York Heart Association \[NYHA\] class III or IV) within 6 months
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
* Lack of availability of a patient for immunological and clinical follow-up assessment
* Known pulmonary hypertension
* Known hypersensitivity to sirolimus
* Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator's opinion will prevent completion of the protocol therapy or follow-up
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug; (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the subject's risk by participating in this study)
* Received an investigational agent within 30 days prior to enrollment
* Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01522820
Study Brief:
Protocol Section:
NCT01522820