Status:
COMPLETED
Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anaplastic Astrocytoma
Anaplastic Oligoastrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best schedule of vaccine therapy with or without sirolimus in treating patients with cancer-testis antigen (NY-ESO-1) expressing solid tumors. Biologica...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety of DC205-NY-ESO-1 vaccine (DEC-205/NY-ESO-1 fusion protein CDX-1401) with and without sirolimus. Toxicity as defined by the National Cancer Institute (NCI)...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01522820
Start Date
March 1 2012
End Date
July 1 2016
Last Update
October 4 2016
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263