RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-07-16

Study Completion:2030-05-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03965234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Todd L Demmy

PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

Todd L Demmy, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-16

Study Completion Date2030-05-25

Study Record Updates

Study Start Date2020-07-16

Study Completion Date2030-05-25

Terms related to this study

Additional Relevant MeSH Terms

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