NCT03778996Active, not recruitingPhase 2
SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma
Phase 2 Clinical Trial to Evaluate Efficacy and Safety of SM-88 Used With Methoxsalen, Phenytoin, and Sirolimus (MPS) as Maintenance Therapy Following Standard Treatments for Ewing's Sarcoma or as Salvage Therapy for Advanced Sarcomas
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 6 Dec 2018
- Start date
- 3 Jan 2020
- Primary completion date
- 19 Dec 2027
- Lead sponsor
- Sarcoma Oncology Research Center, LLC
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT03778996
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 3 Jan 2020 to the primary completion date, 19 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic anticancer agents within 14 days prior to treatment on study
- Major surgery within 30 days
- Prior treatment with SM-88
- Current or anticipated treatment with a contraindicated medication
Other illness
- 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
- Evidence of viral infections including human immunodeficiency virus (HIV), hepatitis B, and hepatitis C
Lab values
- 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
Who the study is looking for
- 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:
- Maintenance treatment cohort : 1-3 prior lines of systemic treatment (including current treatment)
- Salvage cohort: Any number of prior treatments
- Maintenance treatment cohort only: Patient completed current line of treatment (systemic, surgery, radiation) prior to enrollment, without disease progression as compared to baseline AND has achieved at least one of the following
- CR in response to current second or third line treatment
- PR in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy)
- SD in response to current line of treatment (after at least 4 cycles, if treatment included systemic therapy)
- Measurable disease, except for patients in Cohort A who have achieved CR at the conclusion of current 2nd or 3rd line of treatment
- ECOG performance status 0-2
- Adequate organ function defined as all laboratory parameters ≤ Grade 2 NCI CTCAE criteria
- Patients must be able to swallow and retain whole capsules
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sarcoma Oncology Research Center Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.