Recruiting
Phase 1
Phase 2

Pulmonary Suffusion

Sponsor:

Roswell Park Cancer Institute

Code:

NCT03965234

Conditions

Metastatic Bone Sarcoma

Metastatic Malignant Neoplasm in the Lung

Metastatic Soft Tissue Sarcoma

Metastatic Unresectable Sarcoma

Resectable Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cisplatin

Isolated Chemotherapeutic Lung Perfusion

Metastasectomy

Study Details

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.

The Phase 1 portion of the study has been completed.

Conditions

Metastatic Bone Sarcoma

Metastatic Malignant Neoplasm in the Lung

Metastatic Soft Tissue Sarcoma

Metastatic Unresectable Sarcoma

Resectable Sarcoma

Study ID

NCT03965234

Start date

Jul 16, 2020

Status verified date

Aug, 2026

Completion date

May 25, 2030

Anticipated

Primary completion date

May 25, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Tumors metastatic to the lungs that are the focus of this protocol specifically:

  • Colorectal carcinoma
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
  • Hemoglobin > 8.0 g/L
  • Neutrophils > 1,500 uL
  • Platelets >= 100,000 uL
  • Creatinine clearance >= 30 mL/min
  • Clinically diagnosed 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 stereotactic body radiation therapy (SBRT) or microwave ablation, a hybrid approach to eliminate all sites of disease will be permitted; however, supplemental approaches should be delayed, if possible, until after the 30 day post-suffusion endpoint
  • Pulmonary function judged by the surgeon to be sufficient to tolerate the planned pulmonary metastasectomy. Testing is not required but generally is performed clinically and will be left to the discretion of the treating surgeon. The following are not required but serve as guidelines since they were used to determine eligibility for the Phase I protocol: EV1 >= 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 affirmation that suffusion and resection or ablation of all nodules is technically feasible
  • Control of the primary tumor as determined by clinical assessment per standard of care; may include stable tumor status of primary tumor and other metastases, in the clinical judgement of the PI/consulting physician.
  • 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:

  • 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 chemotherapy drugs that may be used in the procedure
  • Pregnant or nursing female participants
  • Unwilling or unable to follow protocol requirements
  • Pulmonary metastases unable to be completely resected or ablated based on pre-registration review of imaging by a thoracic surgeon or proceduralist.
  • Any additional condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug or the suffusion technique, may include uncontrolled intercurrent illness and other conditions that, in the judgement of the PI/Physician, would limit compliance with the study requirements and have safety concerns
  • Received an investigational agent within 30 days prior to enrollment
  • Severe peripheral neuropathy

Study Design

Enrollment

99 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prevention (cisplatin, metastasectomy)

Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients the undergo metastasectomy. Beginning 4-8 weeks, patients with unresectable sarcoma may receive chemotherapy.

Interventions

Cisplatin

Given via infusion

Isolated Chemotherapeutic Lung Perfusion

Undergo pulmonary suffusion

Metastasectomy

Undergo metastasectomy

Primary outcome measure

  • Incidence of local toxicities (Phase I) [ Time Frame: Up to 2 years ]
  • Recommended phase II dose (Phase I) [ Time Frame: Up to 5 years ]
  • Local recurrence (Phase II) [ Time Frame: From resection until local recurrence in the suffused lung or last clinic follow-up, assessed up to 2 years ]
  • Incidence of local and systemic toxicities (Phase II) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Kenneth Seastedt

716-845-2300Kenneth.Seastedt@Roswellpark.org

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Kenneth Seastedt, MD

716-845-8675Kenneth.Seastedt@roswellpark.org

Principal Investigator:

Kenneth Seastedt

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-21.