Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases
Roswell Park Cancer Institute
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.
Description
PRIMARY OBJECTIVES: I. To assess the safety of chemotherapy isolated to the pulmonary circulation by determining the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of each chemotherapy agent. (Phase I) II. To determine the rate of local recurrences in patients receiving pulmonary suffusion, compared to historical controls in patients with completely resected pulmonary metastases (unilateral and bilateral disease). (Phase II) SECONDARY OBJECTIVES: I. To determine the local and systemic toxicities associated with pulmonary suffusion. (Phase I) II. To determine whether su…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 suspici…
Interventions
- DrugCisplatin
Given via infusion
- ProcedureIsolated Chemotherapeutic Lung Perfusion
Undergo pulmonary suffusion
- ProcedureMetastasectomy
Undergo metastasectomy
Location
- Roswell Park Cancer InstituteBuffalo, New York