Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Soft Tissue or Bone Sarcoma Metastatic to the Lungs

• Status: Recruiting
• Trial end date: 2030-05-25
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with soft tissue or bone sarcoma 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Soft tissue or bone sarcoma metastatic to the lungs

• 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 metastasis(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)

• Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present

• Forced expiratory volume in 1 second (FEV1) >= 50% predicted

• Diffusion capacity of the lung for carbon monoxide (DLCO) >= 50% predicted

• Vital capacity (VC) >= 50% predicted

• Ambulatory and resting oxygen (O2) saturation > 88%

• Six minute walk >= 50 % of the expected distance

• Surgeon and interventional radiologist affirmation that suffusion is technically feasible

• Borg Dyspnea scale (modified) < 5

• Control of the primary sarcoma tumor by imaging performed =< 1 month prior to study enrollment

• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Use of home oxygen

• Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

• Allergy, intolerance, or other serious reaction to cisplatin

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac conditions ( ike congestive heart failure, angina pectoris, and arrhythmias that are unstable or refractory to management) or psychiatric illness/social situations that would limit compliance with study requirements

• Pregnant or nursing female participants

• Unwilling or unable to follow protocol requirements

• Any additional condition which in the Investigator?s opinion deems the participant an unsuitable candidate to receive study drug or the suffusion technique

• Received an investigational agent within 30 days prior to enrollment

• Severe peripheral neuropathy