Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
Phase I/ II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 months, 1 year, 5 years
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "To correlate local disease control with tumor biomarker for metastasis (circulating \[circ\] ribonucleic acid \[RNA\], micro \[mi\]RNA). (Phase II) OUTLINE: Patients undergo pulmonary suffusion consisting of cisplatin via infusion."
- "After completion of study treatment, patients are followed up for 3 months for one year and then every 6 months for up to 5 years."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the side effects of pulmonary suffusion, a procedure that sends cancer drugs such as cisplatin directly into lung tissue, and whether it controls small amounts of cancer left behind. The study description mentions sarcoma and colorectal cancer that have spread to the lungs, but the listed entry rules name only colorectal cancer (cancer of the colon or rectum). Phase 1 is complete.
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. The Phase 1 portion of the study has been completed.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have colorectal cancer that has spread to the lungs, as diagnosed by the care team.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- Have blood tests that meet the study’s limits for red blood cells, infection-fighting cells, and cells that help stop bleeding.
- Have kidney function that meets the study’s minimum level.
- Have lungs strong enough for the planned lung surgery, as judged by the surgeon.
- The surgeon must judge that the lung drug treatment is possible and all lung tumors can be removed or destroyed.
- Have the original cancer under control. The study doctor may accept cancer that is stable, including other areas where it has spread.
- Understand the study and sign a consent form. If able to become pregnant, agree to use birth control before joining.
Who can't join
- Had chemotherapy or radiation within 4 weeks before joining, or within 6 weeks for nitrosoureas or mitomycin C; or have not recovered from side effects of earlier treatment.
- Have cancer that has spread to the brain.
- Have an allergy, cannot tolerate, or have had another serious reaction to cancer drugs that may be used.
- Are pregnant or breastfeeding.
- Are unwilling or unable to follow study rules.
- Have lung tumors that cannot all be removed or destroyed, based on a specialist’s review of scans.
- Have another condition the study doctor believes makes treatment unsafe or unsuitable, or have severe peripheral neuropathy (nerve damage, often in the hands or feet).
- Received an experimental drug within 30 days before joining.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Tumors metastatic to the lungs that are the focus of this protocol specifically: * Colorectal carcinoma * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Hemoglobin \> 8.0 g/L * Neutrophils \> 1,500 uL * Platelets \>= 100,000 uL * Creatinine clearance \>= 30 mL/min * Clinically diagnosed 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 stereotactic body radiation therapy (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 * Pulmonary function judged by the surgeon to be sufficient to tolerate the planned pulmonary metastasectomy. Testing is not required but generally is performed clinically and will be left to the discretion of the treating surgeon. The following are not required but serve as guidelines since they were used to determine eligibility for the Phase I protocol: EV1 \>= 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 and resection or ablation of all nodules is technically feasible * 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/consulting 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
Study sites (1)
NY
- Roswell Park Cancer Institute · Buffalo, NY 14263Kenneth Seastedt, MD · Study contact · 716-845-8675 · Kenneth.Seastedt@roswellpark.orgKenneth Seastedt · Principal investigatorMore trials in Buffalo