Sunitinib for Advanced Thymus Cancer Following Earlier Treatment
- 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.
- To see if sunitinib is a safe and effective treatment for advanced thymus cancer that has not responded to earlier treatments.
- 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.
- 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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Sunitinib in Patients With Advanced Relapsed or Refractory Thymoma or Thymic Carcinoma With at Least One Prior Line of Platinum-Based Systemic Chemotherapy|
- To evaluate the objective response rate (PR+CR) for sunitinib in patients with relapsed or refractory thymoma or thymic carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine the progression-free survival and overall survival for sunitinib in patients with relapsed or refractory thymoma or thymic carcinoma. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- To assess safety and tolerability of sunitinib. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2019|
|Estimated Primary Completion Date:||April 2019 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Single Group Assignment for Thymoma and Thymic Carcimoma
50mg/day for 4 weeks daily, by mouth with 2 weeks off (6 week cycle)
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.
- To evaluate the objective response rate (PR+CR) for sunitinib in patients with relapsed or
refractory thymoma or thymic carcinoma
- To determine the progression-free survival (PFS) and overall survival (OS) for sunitinib in patients with relapsed or refractory thymoma or thymic carcinoma
- To assess safety and tolerability of sunitinib
- To assess the duration of response to sunitinib
- Patients with histologically confirmed thymoma 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 RECIST 1.1 criteria
- Adequate renal, hepatic and hematopoietic function
- No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of sunitinib
- 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 CTCAE Version 4.0
- 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 VEGFR2, PLGF, IL-4, IL-12, HGF, and b-FGF (Group 1 only); and circulating tumor cells, endothelial progenitors, and mature apoptotic endothelial cells (both groups). In Group 2, regulatory T cells (Tregs), exhausted CD8 T cells, myeloid-derived suppressor cells (MDSCs), and Th1/Th2 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 NCI only.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621568
|Contact: Arlene W Berman, R.N.||(301) email@example.com|
|Contact: Arun Rajan, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Arun Rajan, M.D.||National Cancer Institute (NCI)|