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

Korábbi kezelés

• 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
• Received an investigational agent within 30 days prior to enrollment

Más betegség

• Allergy, intolerance, or other serious reaction to chemotherapy drugs that may be used in the procedure
• 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

Egyéb

• 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
• 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.
• Severe peripheral neuropathy

• 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