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

Send

Updated on 4 October 2022

See if I qualify

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 Identifier	NCT03965234
Sponsor	Roswell Park Cancer Institute
Last Modified on	4 October 2022

How understandable was the trial content above?

Hard to understand

Easy to understand

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

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

isolated chemotherapeutic lung perfusion

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Edit Delete

Added by •

•

Private

Edit Delete

Reply by • • Private

Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

Enter the passcode

The passcode will expire in None.

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