Clinical Trials Logo

Clinical Trial Summary

Background: - Sunitinib is drug that is approved for treating various types of cancers, including kidney cancers. However, it has not been approved to treat cancers of the thymus. Sunitinib works by blocking proteins that are responsible for cell division and growth. Some of these proteins can be found on thymus cancer cells. Researchers want to see if sunitinib can be used to treat advanced thymus cancer. It will be given to people who have had at least one earlier chemotherapy treatment containing platinum. Objectives: - To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has not responded to earlier treatments. Eligibility: - Individuals at least 18 years of age who have advanced thymus cancer that has not responded to earlier treatments. - At least one previous cancer treatment must have been chemotherapy treatment containing platinum. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor biopsies will be used to check the severity of the cancer. - Participants will take sunitinib tablets once a day, in the morning. They will take the tablets daily for 4 weeks, followed by 2 weeks of rest with no sunitinib. This 6-week period is called a cycle. - Treatment will be monitored with frequent blood tests and imaging studies. - Treatment cycles may be repeated as long as the tumor does not continue to grow and there are no severe side effects....


Clinical Trial Description

BACKGROUND: Platinum-based chemotherapy is the standard of care for advanced unresectable thymoma and thymic carcinoma. However over 50% of these patients may fail initial therapy and therefore require second-line therapy. New therapeutic options are needed for patients who have disease progression on or after platinum-containing therapy. Results obtained from protocol 12-C-0118 so far have shown impressive clinical activity of sunitinib in patients with recurrent thymic carcinoma with an objective response rate of 23% and disease control rate of 91% which is unprecedented for this histology. Treatment at a dose of 50 mg once daily for four weeks followed by 2 weeks off was poorly tolerated. Twenty five out of 41 patients needed dose reductions due to development of intolerable adverse events. OBJECTIVES: Primary objective: - To evaluate the objective response rate (Partial Response (PR)+Complete Response (CR) for sunitinib in patients with relapsed or refractory thymoma or thymic carcinoma MAIN ELIGIBILITY: - Patients with histologically confirmed thymoma (Group 1 only) or thymic carcinoma who have previously been treated with at least one platinum-containing chemotherapy regimen with progressive disease prior to study entry - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria - Adequate renal, hepatic and hematopoietic function - No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of sunitinib DESIGN: - In the first group (Group 1), sunitinib will be administered orally using a continuous schedule at 50 mg per day for 4 weeks with 2 weeks off to constitute a 6-week cycle (Schedule 4/2) until disease progression or development of intolerable side-effects. - In the second group (Group 2), sunitinib will be administered orally using a continuous schedule at 50 mg per day for 2 weeks with 1 week off to constitute a 3-week cycle (Schedule 2/1) until disease progression or development of intolerable side-effects. - Toxicity will be assessed every cycle by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 - Tumor response assessments by RECIST 1.1 criteria will be performed every cycle for Group 1 and every other cycle for Group 2 (every 6 weeks) for patients receiving treatment for less than one year, and every two cycles for Group 1 and every four cycles for Group 2 (every 12 weeks) for patients who have been receiving treatment one year or longer. - Exploratory studies include evaluation of serum vascular endothelial growth factor (VEGF), placental growth factor (PlGF), interleukin 4 (IL-4), interleukin 12 (IL-12), hepatocyte growth factor (HGF), and basic fibroblast growth factor (bFGF) (Group 1 only); and circulating tumor cells, endothelial progenitors, and mature apoptotic endothelial cells (both groups). In Group 2, regulatory T cells (Tregs), exhausted cluster of differentiation 8 (CD8) T cells, myeloid-derived suppressor cells (MDSCs), and Type 1 T helper (Th1)/Type 2 T helper (Th1) T cell populations will also be evaluated. Where tumor samples are available, intra-tumoral immune infiltrate will be assessed (both groups). Exploratory studies apply to National Cancer Institute (NCI) only. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01621568
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 15, 2012
Completion date July 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT00818090 - Paclitaxel and Cisplatin for Thymic Neoplasm Phase 2
Completed NCT00332969 - Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma Phase 2
Completed NCT00921739 - Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies Phase 1
Recruiting NCT05255965 - IL-8+ naïve T Cells as a Biomarker for Thymoma Identification
Withdrawn NCT02948855 - Regulation of LncRNA For Breg in Patients With Thymoma and Autoimmune Diseases
Completed NCT00387868 - Preoperative Treatment of Patients With High Risk Thymoma Phase 2
Completed NCT01272817 - Nonmyeloablative Allogeneic Transplant N/A
Recruiting NCT03466827 - Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma Phase 2
Completed NCT02220855 - A Study of BKM120 (Buparlisib) in Relapsed or Refractory Thymomas Phase 2
Completed NCT03288662 - Relationship Between Computed Tomography Manifestation and Histopathological Classification of Thymic Epithelial Tumors N/A
Active, not recruiting NCT01242072 - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies Phase 1
Recruiting NCT06029621 - Robot-assisted vs VATS for Thymoma N/A
Active, not recruiting NCT03921671 - Ramucirumab and Carbo-Paclitaxel for Untreated Thymic Carcinoma / B3 Thymoma With Carcinoma (RELEVENT) Phase 2
Recruiting NCT05262582 - Comparison of Single Port and Two Ports Robotic Assisted Thoracic Surgery for Thymectomy N/A
Terminated NCT01100944 - A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies Phase 1/Phase 2
Active, not recruiting NCT03968315 - An Investigational Scan (MRI) in Imaging Patients With Newly-Diagnosed or Recurrent Thymoma N/A
Recruiting NCT04162691 - Single Cell Sequencing Analysis of Thymoma
Recruiting NCT06086327 - Application of 68Ga-Pentixafor PET/CT for Thymoma Early Phase 1
Completed NCT01364727 - A Phase 2 Study of Amrubicin in Relapsed or Refractory Thymic Malignancies Phase 2