← Back to Clinical Trials
Recruiting Phase 1, Phase 2 NCT03965234

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases

Trial Parameters

Condition Metastatic Bone Sarcoma
Sponsor Roswell Park Cancer Institute
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 99
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-07-16
Completion 2029-05-25
Interventions
CisplatinIsolated Chemotherapeutic Lung PerfusionMetastasectomy

Brief Summary

This phase I/II trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally.

Eligibility Criteria

Inclusion Criteria: * Tumors metastatic to the lungs that are the focus of this protocol specifically: * Soft tissue sarcoma * Osteosarcoma * Colorectal carcinoma * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Hemoglobin \> 8.0 g/L * Granulocytes \> 1,500 uL * Platelets \>= 100,000 uL * Creatinine clearance \>= 30 mL/min * Clinically diagnosed resectable sarcoma lung metastases(while preregistration histologic or cytologic confirmation is desirable, this may not be required in clinical scenarios where a biopsy may not change the need to resect suspicious lung nodules or the biopsy itself poses a risk for tumor seeding. In such cases, the diagnosis will be supported by rapid pathologic evaluations intraoperatively before proceeding with Suffusion) Given the emergence of other acceptable options to destroy lung metastases such as SBRT or microwave ablation, a hybrid approach to eliminate all sites of disease will be permitted; however, supplemental appr

Related Trials