BridgeMD
New treatment option for Locally Advanced Lung Non-Small Cell Carcinoma
Official title Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05136846
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for locally advanced lung non-small cell carcinoma.
Also referred to as Blastocarb, Carboplat.
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 trial finds out the best dose, possible benefits and/or side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process.
- Phase 1: an early, usually small safety study
- 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
- All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\< grade 1 (except alopecia) at...
- Absolute neutrophil count \>=1.5 x 10\^9/L
- Hemoglobin \>= 9 g/dL
- Platelets \>= 100 x 10\^9/L
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
You likely can't join if
- Patients with history of pneumonectomy
- History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
- History of previous radiation therapy which would result in overlapping radiation fields
- people who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study...
- Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST/ALT)
- Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study
See the full eligibility criteria
Who can join
- All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\< grade 1 (except alopecia) at the time of enrollment
- Absolute neutrophil count \>=1.5 x 10\^9/L
- Hemoglobin \>= 9 g/dL
- Platelets \>= 100 x 10\^9/L
- Total bilirubin =\< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- Creatinine \ = 50 mL/min or 24-hour urine creatinine clearance \>= 50 mL/min
- Calculated by the Cockcroft-Gault formula \>= 18 years old
- Non-small cell lung cancer (NSCLC), histologically and/or cytologically proven
- Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.
- For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic...
- Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the...
- Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC
- Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible
- Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest/abdomen/pelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast...
- Patients must have vital signs, history/physical examination, laboratory studies (complete blood count [CBCP] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment...
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism
- Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment
- Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment
- Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen
- Women/men of reproductive potential must be counselled on contraception/ abstinence while receiving the study treatment
- Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration
- For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment FOR MRI IMAGING SUB-STUDY: Patients must consent to...
What rules you out
- Patients with history of pneumonectomy
- History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis
- History of previous radiation therapy which would result in overlapping radiation fields
- people who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while...
- Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST/ALT)
- Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study
- Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or...
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry...
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
- Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment
- Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine EXCLUSION CRITERIA...
- Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)
- Severe anxiety/claustrophobia related to MR imaging despite medications to relieve anxiety/claustrophobia
- Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Columbus, Ohio, 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 Duarte, California, United States; Columbus, Ohio, 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.