modafinil and Ewing Sarcoma

modafinil has been researched along with Ewing Sarcoma in 2 studies

Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.
2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group.

Research

Studies (2)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Overall Response Rate (ORR)

ORR is defined as the proportion of participants who have prolonged stable disease or a partial or complete response or complete response to therapy according to RECIST 1.1. (NCT03495921)
Timeframe: 6 months after treatment with Vigil.

Overall Survival (OS)

OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death. (NCT03495921)
Timeframe: From date of randomization until date of death from any cause, whichever came first (assessed up to 3 years).

Progression Free Survival (PFS)

Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1) for target lesions and assessed CT/MRI by local investigator. (NCT03495921)
Timeframe: From date of randomization until the date of first documented progression (assessed up to 3 years).

Vigil Manufacture Success Rate: Number of Participants Eligible for Treatment on the Main Study.

Participants were considered eligible for treatment, if the tissue submitted to Gradalis met all criteria, including manufacturing product release criteria. (NCT03495921)
Timeframe: From manufacturing start date until 4 weeks post manufacturing for each tissue procurement (assessed up to 17 months).

Number of Participants With Adverse Events Determined by Laboratory Assessments and Physical Examinations

"To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolomide with 30 days of last dose in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy.~• To determine safety profile of Vigil immunotherapy in combination with irinotecan and temozolimidetemozolomide in patients with metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy." (NCT02511132)
Timeframe: 30 days of last treatment dosing

Overall Survival

OS is defined as time from randomization to death or to the date of last follow-up. The date of last follow-up confirming survival will be used as the censoring date for subjects who are alive and/or do not have a known date of death. (NCT02511132)
Timeframe: Estimated median 2 years

Progression Free Survival

Progression Free Survival (PFS) is defined as the time from randomization to the event of disease recurrence/progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause. To determine the progression free survival of subjects dosed with Vigil immunotherapy in combination with irinotecan and temozolomide. (NCT02511132)
Timeframe: Estimated median 1.3 years

Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)

To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose. (NCT01505166)
Timeframe: Baseline, End of Treatment (30 days after last dose) up to 12 months

Number of Participants Positive for T-cell and Immune Activation Markers

Gamma interferon (γ-IFN) secretion measured by ELISpot assay was used as a marker for T-cell and immune activation to cancer specific neoantigens. Any participant that had greater than or equal to 10 spots were considered positive. (NCT01309230)
Timeframe: Blood was collected at tissue procurement, prior to the 1st and 3rd cycles of chemotherapy post debulking, at screening, months 2, 4, 6, end of treatment, and quarterly until recurrence, up to 3 years.

Time to Recurrence (TTR)

Time to recurrence is the time to progression by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. Disease recurrence was defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels >35 U/mL at two consecutive measurements, at least one month apart. (NCT01309230)
Timeframe: Treatment start to the date of first recurrence or date of death if the participant died before recurrence. Radiographic assessment at baseline, 35 U/mL, approximately 3 years.

Vigil Related Adverse Events (AEs)

AEs were reported using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. (NCT01309230)
Timeframe: From first dose of Vigil until 30 days following last dose of Vigil, up to 13 months.

Other Studies

2 other studies available for modafinil and Ewing Sarcoma