SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma (NCT03778996) | Clinical Trial Compass
Active — Not RecruitingPhase 2
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
United States31 participantsStarted 2020-01-03
Plain-language summary
The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts:
* Clinically advanced Ewing's Sarcoma patients who have not progressed at the conclusion of systemic treatment
* Clinically advanced sarcoma patients in the salvage treatment setting
Up to 24 efficacy evaluable patients (up to 12 per cohort) will be enrolled. Study patients will receive oral SM-88, with scheduled safety and efficacy evaluations.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to understand and willingness to provide written informed consent to participate in this study
. ≥12 years of age
. Diagnosis:
. Maintenance treatment cohort: Histologic or cytologic diagnosis of Ewing's sarcoma, including non-resected, locally advanced or metastatic disease
. Salvage treatment cohort: Non-resected, locally advanced or metastatic sarcoma (including Ewing's sarcoma) for which there is no standard of care treatment and no curative other option
. Radiographic disease assessment within 35 days prior to enrollment and planned treatment start with study drug
. Prior treatment:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate
Timeframe: Every 3 months for up to 2 years
2
Stable Disease for at Least 3 Months
Timeframe: Every 3 months for up to 2 years
3
Progression Free Survival on Study of at Least 1.5 Times the Duration of PFS for the Last Prior Treatment
. Maintenance treatment cohort : 1-3 prior lines of systemic treatment (including current treatment)
Exclusion criteria
. Systemic anticancer agents within 14 days prior to treatment on study
. Major surgery within 30 days
. Prior treatment with SM-88
. Any screening laboratory, electrocardiogram (ECG), other clinical finding, comorbidity or clinical history that, in the opinion of the investigator, indicates an unacceptable risk for patient to participate in the study or would limit patient's ability to comply with study requirements
. History of any drug allergies or significant adverse reactions to any of the components of SM-88
. History of light sensitive diseases for which methoxsalen would be contraindicated
. Current or anticipated treatment with a contraindicated medication
. Evidence of viral infections including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C