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Alkylating agents

Pulmonary Suffusion for Lung Metastases

Phase 1 & 2
Recruiting
Led By Todd L Demmy
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Six minute walk >= 50 % of the expected distance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a minimally invasive way to deliver chemo drugs to lung tissues to see if it can control the spread of sarcomas.

Who is the study for?
This trial is for patients with sarcoma or colorectal cancer that has spread to the lungs, who can undergo a special procedure called pulmonary suffusion. They must have controlled primary tumors, be able to walk a certain distance, and not need home oxygen. Participants should agree to use contraception and not be pregnant.Check my eligibility
What is being tested?
The study tests pulmonary suffusion—a way of delivering chemotherapy directly into lung tissue—to control minimal residual disease in lung metastases from sarcoma or colorectal cancer. Cisplatin is the chemotherapeutic agent used in this minimally invasive technique.See study design
What are the potential side effects?
Possible side effects include reactions related to cisplatin such as nausea, vomiting, kidney damage, hearing loss, nerve problems like numbness or tingling sensations (neuropathy), and an increased risk of infection due to lowered blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I can walk at least half the distance expected for someone my age and size in six minutes.
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My oxygen levels stay above 88% whether I'm moving or resting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of local toxicities (Phase I)
Local recurrence (Phase II)
Recommended phase II dose (Phase I)
Secondary outcome measures
Disease-free survival (Phase II)
Incidence of local and systemic toxicities (Phase I)
Incidence of local and systemic toxicities (Phase II)
+1 more
Other outcome measures
Immune markers (Phase II)
Lung injury (% reduction of spirometry and differential reduction by quantitative perfusion scan) (Phase II)
Overall survival (Phase II)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (cisplatin, metastasectomy)Experimental Treatment3 Interventions
Patients undergo pulmonary suffusion consisting of cisplatin via infusion. Patients the undergo metastasectomy. Beginning 4-8 weeks, patients with unresectable sarcoma may receive chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Metastasectomy
2010
N/A
~100

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,708 Total Patients Enrolled
11 Trials studying Sarcoma
339 Patients Enrolled for Sarcoma
Todd L DemmyPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03965234 — Phase 1 & 2
Sarcoma Research Study Groups: Prevention (cisplatin, metastasectomy)
Sarcoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03965234 — Phase 1 & 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03965234 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the aims of this medical experiment?

"Over the span of two years, this clinical trial will assess a recommended Phase II dosage. The primary objectives include assessing local and systemic toxicities with NCI CTCAE v5.0, disease-free survival using Kaplan-Meier methods to estimate median and 2-year survival rates with 90% confidence intervals, as well as gauging incidence of toxicity in each arm through frequencies and relative frequencies."

Answered by AI

Are there any prior investigations regarding Isolated Chemotherapeutic Lung Perfusion?

"Presently, 746 separate clinical trials for Isolated Chemotherapeutic Lung Perfusion are ongoing. Of these studies, 289 have reached the final phase of testing. Most of these experiments take place in Shanghai; however, 44121 different sites are running trials related to this research topic."

Answered by AI

What is the current capacity for enrolment into this research project?

"Correct. Per the information found on clinicaltrials.gov, this medical trial is currently enrolling participants which began recruitment on July 16th 2020 and was last updated November 22nd 2022. The study needs to acquire 99 patients from one center in total."

Answered by AI

Are there any available opportunities for participants to join this experiment?

"According to clinicaltrials.gov, this medical trial is still open for enrolment. The first post was shared on July 16th 2020 and the listing has been revised as recently as November 22nd 2022."

Answered by AI

What medical conditions is Isolated Chemotherapeutic Lung Perfusion employed to address?

"Isolated Chemotherapeutic Lung Perfusion is often utilized to treat neoplasm metastasis, but can also be beneficial in treating advanced ovarian cancer unresponsive to traditional treatments, as well as certain advance directives."

Answered by AI
~57 spots leftby May 2029