Track topics on Twitter Track topics that are important to you
- Cisplatin-containing chemotherapy is the standard of care for advanced thymoma and thymic carcinoma that cannot be treated with surgery. New options for treatment are necessary in patients with advanced thymoma and thymic carcinoma that have progressed on cisplatin-containing therapy.
- IMC-A12 is a new (experimental) agent that has not yet been approved by the Food and Drug Administration. IMC-A12 blocks the Insulin-like Growth Factor 1 receptor (IGF-1R). IGF-1R is found on many types of cancer cells, including cancer of the thymus, and is thought to play an important role in helping these cells to grow and divide.
- To determine if IMC-A12 has an effect on tumor growth in patients with cancer of the thymus.
- To evaluate the safety and tolerability of IMC-A12 in treatment for cancer of the thymus.
- Individuals older than 18 years of age who have cancer of the thymus (thymoma, thymic carcinoma, or thymic carcinoid tumors) that has progressed in spite of standard treatment.
- Treatment will take place in 21-day cycles. Patients will receive one dose of IMC-A12 intravenously once every 3 weeks at the Clinical Center. During the Clinical Center visits, researchers will perform study tests and procedures to see how the study drugs are affecting the body.
- Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, blood and urine samples for standard tests, imaging studies (ultrasound, magnetic resonance imaging (MRI) or computed tomography (CT) scans) to evaluate tumor growth, and blood and urine samples to evaluate the amount of IMC-A12 in the body.
- Patients may continue to take the drug as long as there are no adverse side effects and as long as the tumor does not grow.
Cisplatin-containing chemotherapy is the standard of care for advanced unresectable thymoma and thymic carcinoma. New options for treatment are necessary in patients with advanced thymoma and thymic carcinoma that have progressed on cisplatin-containing therapy. The insulin-like growth factor (IGF) pathway is being studies in various malignancies including thymoma and thymic carcinoma. IMCA12 is an anti-IGF-1R monoclonal antibody that has shown activity in patients with thymic malignancies.
- To determine the objective response rate (PR+CR) to IMC-A12 monotherapy in patients with advanced or recurrent thymoma or thymic carcinoma.
- To evaluate time to response, duration of response, progression-free survival (PFS) and overall survival (OS)
- To assess safety of IMC-A12
- To perform immunohistochemistry for IGF1R expression on tumor samples of thymoma and thymic carcinoma (exploratory)
- To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging
- To perform pharmacokinetic PK analysis of IMC-A12
- To perform pharmacodymanic (PD) analysis in blood for the dectection of IGF1R, AKT and pAKT in PBMC's (exploratory).
- To assess circulating endothelial cell, circulating endothelial progenitor cells, immune subset analysis and glucose transport in peripheral blood monocytes and lymphocytes (exploratory).
- To evaluate anti-cytokine antibodies in peripheral blood (exploratory).
- Patients with histologically confirmed thymic carcinoma or thymoma who have previously been treated on at least one platinum-containing chemotherapy regimen
- Measurable disease by RECIST criteria
- Adequate renal, hepatic and hematopoietic function
- No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of IMC-A12 therapy
- Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks
- Treatment with IMC-A12 alone will continue until disease progression
- Toxicity will be assessed every cycle by CTCAE Version 3.0
- Tumor response assessments by RECIST 1.0 criteria will be performed every 2 cycles
- Correlative studies including tissue immunohistochemistry studies will be done on existing tumor blocks
- Blood samples will be collected for for PK's, PD's, CEC's, CEPC's, immune subsets, glucose transport and cytokine antibodies.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Indiana University Simon Cancer Center
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:19:49-0400
There are 2 parts in this study. The goal of Part 1 of this clinical research study is to confirm the highest tolerable dose of pembrolizumab that can be given to patients with unresectab...
This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.
This is a retrospective analysis of biological characteristics of thymoma and thymic carcinoma patients.
This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.
The main purpose of this study is to find out the good and the bad effects that the combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin, and cyclop...
Clinical characteristics, risk factors, and outcomes after adjuvant radiotherapy for patients with thymoma in the United States: Analysis of the Surveillance, Epidemiology, and End Results (SEER) Registry (1988-2013).
The surgery with adjuvant radiation for the treatment of thymoma is still debated. The aim of this study was to examine the efficacy of postoperative radiotherapy (PORT) in a population-based registry...
An 81-year-old woman with a 2-year history of dysphagia detected a cervical mass. Computed tomography showed a thyroid tumor extending through the superior and anterior mediastinum. Incisional biopsy ...
Sclerosing thymoma is an extremely rare mediastinal neoplasm; it was recognized for the first time in 1994 and to date only 15 cases have been reported.
Micronodular thymoma with lymphoid stroma (MTWLS) is a rare type of thymoma that shows a similar pattern but varied morphology and immunophenotype of tumor cells. Because of the extremely limited numb...
Thymoma-associated multiorgan autoimmunity (TAMA) is a recently delineated and rare paraneoplastic syndrome reported in patients with thymoma. The disorder is characterized by graft-versus-host diseas...
A neoplasm originating from thymic tissue, usually benign, and frequently encapsulated. Although it is occasionally invasive, metastases are extremely rare. It consists of any type of thymic epithelial cell as well as lymphocytes that are usually abundant. Malignant lymphomas that involve the thymus, e.g., lymphosarcoma, Hodgkin's disease (previously termed granulomatous thymoma), should not be regarded as thymoma. (From Stedman, 25th ed)
A disorder of neuromuscular transmission characterized by weakness of cranial and skeletal muscles. Autoantibodies directed against acetylcholine receptors damage the motor endplate portion of the NEUROMUSCULAR JUNCTION, impairing the transmission of impulses to skeletal muscles. Clinical manifestations may include diplopia, ptosis, and weakness of facial, bulbar, respiratory, and proximal limb muscles. The disease may remain limited to the ocular muscles. THYMOMA is commonly associated with this condition. (Adams et al., Principles of Neurology, 6th ed, p1459)
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...