This study is designed to explore the potential of the epigenetic agent RRx-001 to sensitize patients who previously received and now have failed a platinum based doublet regimen. RRx-001 is administered with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy.
This is an open label, four 'cohort' study for administration of RRx-001 with autologous blood once weekly followed by or in combination with reintroduction of platinum-based doublet therapy according to the treatment schedule listed below. Small cell carcinoma and ovarian cohort participants will be randomized to 1 of 2 treatment arms, respectively. Neuroendocrine and NSCLC patients will be enrolled to single arms. Participants with SCC will receive one of the following; RRx-001 followed by platinum doublet chemotherapy or platinum based chemotherapy alone. HGNEC, RRx-001 followed by platinum doublet chemotherapy. NSCLC, RRx-001 followed by platinum doublet chemotherapy. Participants with Platinum Refractory/Resistant Ovarian and MMMT will receive one of the following, RRx-001 followed by platinum doublet chemotherapy or chemotherapy alone. Approximately 213 participants will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
139
Stanford University
Palo Alto, California, United States
VA Connecticut Cancer Center
West Haven, Connecticut, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Baptist Health
Lexington, Kentucky, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Henry Ford Allegiance Health
Jackson, Michigan, United States
Washington University
St Louis, Missouri, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Overall Survival
From the time from enrollment until the time of death from any cause or last follow-up. Patients will be followed clinically as outlined in the treatment schedule and will be followed off study for death.
Time frame: From start of treatment through death for up to 64 months from Start of Treatment.
Overall Response Rate (ORR)
Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.
Time frame: Assessed up to 49 months
Disease Control Rate (DCR)
The percentage of patients who have achieved complete response, partial response and stable disease (as per RECIST v1.1), assessed up to 49 months.
Time frame: Assessed up to 49 months
Progression Free Survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
Time frame: Assessed up to 49 months
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