Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT03965234

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases

Led by Roswell Park Cancer Institute · Updated on 2026-03-17

99

Participants Needed

1

Research Sites

514 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have metastatic tumors in the lungs from soft tissue sarcoma, osteosarcoma, or colorectal carcinoma
  • ECOG performance status of 2 or less
  • Hemoglobin greater than 8.0 g/L
  • Granulocytes more than 1,500 per microliter
  • Platelets equal to or greater than 100,000 per microliter
  • Creatinine clearance of at least 30 mL/min
  • Lung metastases that can be surgically removed or treated with ablation
  • Lung function measures: FEV1, DLCO, and vital capacity each at least 50% of predicted
  • Oxygen saturation above 88% at rest and during walking
  • Able to walk at least 50% of the expected distance in six minutes
  • Surgeon confirms pulmonary suffusion is technically possible
  • Borg Dyspnea score less than 5
  • Primary tumor is controlled or stable according to clinical assessment
  • Women of child-bearing potential agree to use effective contraception
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Had chemotherapy or radiotherapy within 4 weeks prior to the study (6 weeks for certain drugs) or have not recovered from previous treatment side effects
  • Known brain metastases
  • Allergy or serious reaction to chemotherapy drugs used in the study
  • Pregnant or nursing
  • Unable or unwilling to follow study procedures
  • Lung metastases that cannot be completely removed or ablated
  • Any condition judged by the investigator to make participation unsafe or unsuitable
  • Received an investigational drug within 30 days before enrollment
  • Severe peripheral neuropathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Roswell Park Cancer Institute

Buffalo, New York, United States, 14263

Actively Recruiting

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Research Team

K

Kenneth Seastedt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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