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

NCT03965234 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: i 70818NCI-2019-02940
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Bone Sarcoma; Metastatic Malignant Neoplasm in the Lung; Metastatic Soft Tissue Sarcoma; Metastatic Unresectable Sarcoma; Resectable Sarcoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

• Incidence of local toxicities (Phase I)

  Dose limiting toxicities (DLTs) will be defined based on the rate of drug-related grade 3-5 adverse events. These will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

  Up to 2 years

• Recommended phase II dose (Phase I)

  Up to 5 years

• Local recurrence (Phase II)

  Will be treated as bivariate time-to-event data. Freedom from local recurrence will be summarized using standard Kaplan-Meier methods and the 2-year local recurrence-free rate will be estimated with a 90% confidence interval calculated using Greenwood's formula.

  From resection until local recurrence in the suffused lung or last clinic follow-up, assessed up to 2 years

Secondary Outcomes (4)

• Incidence of local and systemic toxicities (Phase I)

  Up to 5 years

• Disease-free survival (Phase II)

  From suffusion until recurrence (local or distant), death due to or related to disease, or last follow-up, assessed up to 2 years

• Incidence of local and systemic toxicities (Phase II)

  Up to 5 years

• Local recurrence within the treated (suffusion) and untreated lungs for patients with bilateral disease (Phase II)

  At 2 years

Other Outcomes (3)

• Lung injury (% reduction of spirometry and differential reduction by quantitative perfusion scan) (Phase II)

  Up to 5 years

• Immune markers (Phase II)

  Up to 5 years

• Overall survival (Phase II)

  Up to 5 years

Study Arms (1)

Prevention (cisplatin, metastasectomy)

EXPERIMENTAL

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

Drug: Cisplatin; Procedure: Isolated Chemotherapeutic Lung Perfusion; Procedure: Metastasectomy

Interventions

Cisplatin DRUG

Given via infusion

Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

Prevention (cisplatin, metastasectomy)

Isolated Chemotherapeutic Lung Perfusion PROCEDURE

Undergo pulmonary suffusion

Also known as: isolated lung perfusion

Prevention (cisplatin, metastasectomy)

Metastasectomy PROCEDURE

Undergo metastasectomy

Prevention (cisplatin, metastasectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma; Colorectal Neoplasms

Interventions

Cisplatin; 1,2-diaminocyclohexaneplatinum II citrate; Platinum; Metastasectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Surgical Procedures, Operative

Study Officials

• Kenneth Seastedt

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Seastedt

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 28, 2019
• Study Start: July 16, 2020
• Primary Completion (Estimated): May 25, 2029
• Study Completion (Estimated): May 25, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)