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New treatment option for Metastatic Bone Sarcoma
Official title Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
ClinicalTrials.gov ID: NCT03965234
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic bone sarcoma.
Also referred to as Abiplatin, Blastolem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Received an investigational agent within 30 days prior to enrollment
- Severe peripheral neuropathy
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.