Using pulmonary suffusion to control minimal residual disease in sarcoma and colorectal cancer patients

Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases

This study is testing a new way to deliver chemotherapy directly to the lungs in patients with sarcoma or colorectal cancer that has spread there, to see if it helps control the disease better and is safe to use.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Roswell Park Cancer Institute (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Buffalo, New York)
• Trial ID: NCT03965234 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of pulmonary suffusion, a minimally invasive method for delivering chemotherapy directly to lung tissues, in patients with sarcoma or colorectal cancer that has metastasized to the lungs. The study aims to determine the maximum tolerated dose of chemotherapy agents like cisplatin and assess local recurrence rates compared to historical controls. Secondary objectives include evaluating local and systemic toxicities, disease-free survival, and overall survival rates. The trial also explores changes in the tumor microenvironment and potential immune modulation effects associated with pulmonary suffusion.

Who should consider this trial

Good fit: Ideal candidates include patients with resectable lung metastases from soft tissue sarcoma, osteosarcoma, or colorectal carcinoma who meet specific health criteria.

Not a fit: Patients with non-resectable lung metastases or those with poor performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a targeted treatment option that minimizes systemic side effects while effectively controlling metastatic disease in the lungs.

How similar studies have performed: While the specific approach of pulmonary suffusion is novel, similar localized chemotherapy methods have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

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

  * Soft tissue sarcoma
  * Osteosarcoma
  * Colorectal carcinoma
* 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 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 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
* 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 affirmation that suffusion is technically feasible
* Borg Dyspnea scale (modified) \< 5
* 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/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

Where this trial is running

Buffalo, New York

• Roswell Park Cancer Institute — Buffalo, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Kenneth Seastedt — Roswell Park Cancer Institute
• Study coordinator: Kenneth Seastedt

Conditions: Metastatic Bone Sarcoma, Metastatic Malignant Neoplasm in the Lung, Metastatic Soft Tissue Sarcoma, Metastatic Unresectable Sarcoma, Resectable Sarcoma, Colorectal Cancer