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

  • STATUS
    Recruiting
  • End date
    May 25, 2030
  • participants needed
    50
  • sponsor
    Roswell Park Cancer Institute
Updated on 4 October 2022
measurable disease
dyspnea
antineoplastic
sarcoma
2 hemoglobin
metastasectomy
isolated chemotherapeutic lung perfusion

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.

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). (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 disease-free survival (DFS) in patients receiving pulmonary suffusion compared to historical controls, in patients with completely resected pulmonary metastases (unilateral and bilateral disease). (Phase II)

EXPLORATORY OBJECTIVES:

I. To evaluate the pulmonary suffusion-associated changes in local tumor microenvironment (TME) and potential of suffusion as an immune modulation enhancement. (Phase II) II. To determine overall survival (OS) in patients receiving pulmonary suffusion compared to historical controls, in patients with completely resected pulmonary metastases (unilateral and bilateral disease). (Phase II) III. To compare histology of tumor samples with previously resected specimens with attention to biomarkers of systemic immune recognition in patients eligible for repeat suffusion. (Phase II) IV. To obtain tumor and systemic immune biomarkers including cytokine activations for correlation with clinical responses. (Phase II) V. To correlate local control with biomarker for tissue effect from chemotherapy (including tissue levels of platinum, alkaline phosphatase [ALP]). (Phase II) VI. To correlate local disease control with tumor biomarker for metastasis (circulating [circ] ribonucleic acid [RNA], micro [mi]RNA). (Phase II)

OUTLINE

Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients then undergo metastasectomy. Patients found to have unresectable sarcoma may receive chemotherapy within 4-8 weeks of metastasectomy.

After completion of study treatment, patients are followed up for 3 months and then every 6 months for up to 5 years.

Details
Condition Metastatic Unresectable Sarcoma, Lung Metastases, Metastatic Bone Sarcoma, Metastatic Malignant Neoplasm in the Lung, Metastatic Soft Tissue Sarcoma, Pulmonary Metastasis, Resectable Sarcoma, Lung Metastasis
Treatment cisplatin, Metastasectomy, Isolated Chemotherapeutic Lung Perfusion
Clinical Study IdentifierNCT03965234
SponsorRoswell Park Cancer Institute
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 as determined by clinical assessment per standard of care
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
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