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The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, in two study cohorts:
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.
Full description
This prospective, open-label, two stage, pilot phase 2 trial evaluates the efficacy and safety of SM-88 in two cohorts of patients: 1) as maintenance therapy following standard primary or palliative treatments for Ewing's sarcoma patients with high risk of relapse or disease progression; and 2) as salvage therapy for patients with clinically advanced sarcomas.
The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, measured as positive efficacy events, including overall response, maintaining stable disease for ≥ 3 months, or progression free survival at least 1.5 times longer than the last prior line of treatment.
Eligible patients will receive daily oral treatment with SM-88, which consists of D,L-alpha-metyrosine, used with methoxsalen, phenytoin, and sirolimus in continuous treatment cycles of 28 days. Treatment will continue until: 1) Symptomatic, clinical progression with radiographic progressive disease; 2) 48 weeks after documented complete response; or 3) evidence of unacceptable toxicity, or other decision to discontinue treatment
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Ability to understand and willingness to provide written informed consent to participate in this study
≥12 years of age
Diagnosis:
Radiographic disease assessment within 35 days prior to enrollment and planned treatment start with study drug
Prior treatment:
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
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
Key Exclusion Criteria:
Primary purpose
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Interventional model
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31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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