Neoplasms

Blood and Lymph Conditions

All Conditions

Thymoma

Thymus Neoplasms

Neoplasms by Histologic Type

Thoracic Neoplasms

Lymphatic Diseases

Anti-Infective Agents

All Drugs and Chemicals

Blood Substitutes

Micronutrients

Povidone-Iodine

Povidone

Iodine

Cadexomer iodine

Intraoperative providone-iodine lavage during resection

Intraoperative providone-iodine lavage

To evaluate whether intraoperative pleural lavage with providone-iodine following complete resection and pleural reductive surgery for stage IVA thymoma reduces recurrent rates compared to surgery without providone-iodine lavage

Following the surgical portion of the procedure, assuming frozen section confirms the suspected diagnosis, pleural lavage using 10% povidone-iodine (warmed to normothermic 37°C) will begin. The 10% povidone-iodine is mixed with sterile water with a dilution of 1/10. A total of 6-14 liters of solution will be prepared in advance of the procedure, pending the size of the patient's chest cavity. The warmed PVP-I will be instilled into the chest cavity to a volume that fills involved thoracic cavity or cavities. Once filled, the solution will be allowed to dwell for 15 minutes. At the conclusion of the 15 minutes, the PVP-I solution will be suctioned out of the chest. This process will be repeated for a total of three dwell sessions.

At the conclusion of the PVP-I lavage, chest tubes should be placed in the chest cavity to re-expand the lung adequately. Chest tube management will be at the discretion of the individual thoracic surgeons, including suction vs water seal and plan for removal.

An honest attempt to maintain the management according to the study protocol will be made. However, if it deemed inappropriate for that patient due to clinical signs, symptoms, or anticipated problems, the surgical team can make whatever changes are deemed necessary. The reason for the deviation must be documented. This patient's data will continue to be collected and analyzed on an intent-to-treat basis for the primary, secondary and tertiary endpoints.

Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies

The Study of Extended Thymectomy and Pleural Reductive Surgery (PRS) With Povidone-iodine Pleural Lavage in Patients With Stage IVA Thymic Malignancies

Progression free survival as compared to that of matched patients in a prospectively enrolled international database of thymic malignancies (ITMIG)

Pleural recurrence will be assessed with CT scans of the chest every 6 months starting 6 months after the index operation and continuing for 3 years. After 3 years, if no recurrence has been identified yet, patients will get CT scans of the chest on an annual basis.

Overall survival will be assessed by regular patient evaluations, which will correspond with the CT scans of the chest. If a patient expires, date and cause of death will be recorded. Causes related to thymic malignancy will be differentiated from other causes of mortality to arrive at disease-specific survival and all-cause overall survival.

Identification of patient and disease characteristics associated with improved responses to providone-iodine lavage.

Variables examined will include demographic data such as age, sex and comorbidities. Additional data evaluated will include specific aspects of the primary thymic tumor such as burden of thoracic disease (confined to mediastinum, extension into ipsilateral pleura, burden of disease in pleura), and pathology characteristics (WHO Type, level of differentiation).

Yale University

Symptoms and General Pathology

Recurrence

Carcinoma

Neoplasms, Glandular and Epithelial

Antineoplastic Agents

Saracatinib

Enzyme Inhibitors

Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

saracatinib

Patrick Loehrer

This phase II trial is studying how well saracatinib works in treating patients with relapsed or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (complete response and partial response) in patients with relapsed or refractory thymoma or thymic carcinoma treated with AZD0530.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of AZD0530 in these patients. II. To evaluate the progression-free survival of these patients. III. To evaluate the overall survival of these patients. IV. To evaluate the disease control rate, defined as complete response, partial response, and stable disease, in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.

Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.

Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.

Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.

National Cancer Institute (NCI)

Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Thymectomy With and Without Povidone-iodine Pleural Lavage in Stage IVA Thymic Malignancies	NCT04371458	Stage IVA Thymo...	Intraoperative ...	18 Years -	Yale University
Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer	NCT00718809	Invasive Thymom... Recurrent Thymo... Stage III Thymo... Stage IVA Thymo... Stage IVB Thymo...	saracatinib	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iva thymoma