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Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors

A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-tumor Immunity in Patients With NY-ESO-1 Expressing Solid Tumors

NCT01522820•Roswell Park Cancer Institute

View on ClinicalTrials.gov

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. Biological therapies, such as sirolimus, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express NY-ESO-1. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. It is not yet known whether vaccine therapy works better when given with or without sirolimus in treating solid tumors.

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) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. SECONDARY OBJECTIVES: I. Assess the NY-ESO-1 specific cellular and humoral immunity: * Peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T-cells. * Peripheral blood NY-ESO-1 specific antibodies. * Peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T-cells. TERTIARY OBJECTIVES: I. Explore time to disease progression. OUTLINE: Patients undergo standard collection of peripheral white blood cells via leukapheresis over 90-240 minutes for vaccine preparation. Patients are assigned sequentially to Cohorts 1a-1d. COHORT 1a: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intranodally on days 1, 29, 57, and 113. COHORT 1b: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus orally (PO) on days 1-14, 29-42, and 57-70. COHORT 1c: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus PO or percutaneous endoscopic gastrostomy (PEG) tube on days 15-28, 43-56, and 71-84. COHORT 1d: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in Cohort 1a and sirolimus PO or PEG on days 1-84. COHORT 2: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 as in the Cohort (1a-1d) that is determined to be safe and produces optimal immunological effects and sirolimus PO on days 1-14 as in Cohort 1b dose. After completion of study treatment, patients are followed up at 6 weeks, 6 months and 12 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+23 more criteria

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
+6 more criteria

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

July 1, 2016

Completion Date

July 1, 2016

Last Updated

October 4, 2016

Enrollment

ACTUAL participants

Conditions

Anaplastic AstrocytomaAnaplastic OligoastrocytomaAnaplastic OligodendrogliomaEstrogen Receptor NegativeEstrogen Receptor PositiveGlioblastomaHormone-Resistant Prostate CancerMetastatic Prostate CarcinomaMetastatic Renal Cell CancerRecurrent Adult Brain NeoplasmRecurrent Bladder CarcinomaRecurrent Breast CarcinomaRecurrent Colorectal CarcinomaRecurrent Esophageal CarcinomaRecurrent Gastric CarcinomaRecurrent Hepatocellular CarcinomaRecurrent Lung CarcinomaRecurrent MelanomaRecurrent Ovarian CarcinomaRecurrent Prostate CarcinomaRecurrent Renal Cell CarcinomaRecurrent Uterine Corpus CarcinomaResectable Hepatocellular CarcinomaSarcomaStage IA Breast CancerStage IA Ovarian CancerStage IA Uterine Corpus CancerStage IB Breast CancerStage IB Ovarian CancerStage IB Uterine Corpus CancerStage IC Ovarian CancerStage II Uterine Corpus CancerStage IIA Breast CancerStage IIA Lung CarcinomaStage IIA Ovarian CancerStage IIB Breast CancerStage IIB Esophageal CancerStage IIB Lung CarcinomaStage IIB Ovarian CancerStage IIB Skin MelanomaStage IIC Ovarian CancerStage IIC Skin MelanomaStage IIIA Breast CancerStage IIIA Esophageal CancerStage IIIA Lung CarcinomaStage IIIA Ovarian CancerStage IIIA Skin MelanomaStage IIIA Uterine Corpus CancerStage IIIB Breast CancerStage IIIB Esophageal CancerStage IIIB Ovarian CancerStage IIIB Skin MelanomaStage IIIB Uterine Corpus CancerStage IIIC Breast CancerStage IIIC Esophageal CancerStage IIIC Ovarian CancerStage IIIC Skin MelanomaStage IIIC Uterine Corpus CancerStage IV Bladder Urothelial CarcinomaStage IV Esophageal CancerStage IV Ovarian CancerStage IV Prostate CancerStage IV Skin MelanomaStage IVA Uterine Corpus CancerStage IVB Uterine Corpus Cancer

Interventions

DEC-205/NY-ESO-1 Fusion Protein CDX-1401

BIOLOGICAL

Laboratory Biomarker Analysis

OTHER

Pharmacological Study

OTHER

Sirolimus

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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RECRUITINGPHASE1/PHASE2

Study of Pembrolizumab and M032 (NSC 733972)

NCT05084430

Glioblastoma MultiformeAnaplastic Astrocytoma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Study of Pembrolizumab and M032 (NSC 733972)

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