The hypothesis is that the addition of mycophenolate mofetil (MMF) and allopurinol to chemotherapy in patients with relapsed small cell lung cancer (SCLC) will be safely tolerated and improve outcomes, as measured by response rate and progression-free survival in patients compared to other single agent chemotherapy drugs used in historical controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Mycophenolate mofetil is commercially available.
Allopurinol is commercially available.
Irinotecan is commercially available.
Washington University School of Medicine
St Louis, Missouri, United States
Number of study treatment related adverse events as measured by NCI-CTCAE v 5.0 (Phase I only)
Time frame: Through 30 days after completion of treatment (estimated to be 5 months)
Overall response rate (ORR) (Phase II and phase I patients who receive the MTD)
* ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1 * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: Through completion of treatment (estimated to be 4 months)
Recommended phase II dose (RP2D) (Phase I only)
-The recommended phase II dose (RP2D) is defined as the dose level at which fewer than 2 patients of a cohort of 6 patients experience dose-limiting toxicity during the first cycle.
Time frame: Completion of cycle 1 (each cycle is 21 days) of all enrolled Phase I participants (estimated to be 10 months)
Number of discontinuations due to treatment related adverse events (Phase I only)
Time frame: Through completion of treatment (estimated to be 4 months)
Number of DLTs in Phase I patients
Time frame: Completion of cycle 1 (each cycle is 21 days) of all enrolled Phase I participants (estimated to be 10 months)
Progression-free survival (PFS) (Phase II and phase I patients who receive the MTD)
-Progression-free survival (PFS), defined as the duration of time from the start date of study treatment to the date of earliest progression or death, whichever occurs first. Patients who neither progress nor die by the data cutoff date will be censored at the last follow up date.
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Time frame: Through 6 months after completion of treatment (estimated to be 10 months)
Overall survival (OS) (Phase II and phase I patients who receive the MTD)
-Overall survival (OS), defined as the duration of time from the start date of study treatment to death from any cause. Patients who are alive by the data cutoff date will be censored at the last follow up date.
Time frame: Through 6 months after completion of treatment (estimated to be 10 months)