Phase 2 gemcitabine + mitomycin C cytotoxics with thalidomide anti-angiogenic immunomodulator

This open-label, single-arm Phase 2 study sponsored by Sarcoma Oncology Research Center, LLC evaluates a “metronomic” (frequent, lower-dose) combination intended to balance disease control with tolerability in patients with advanced/metastatic solid tumors receiving second-line or later therapy. Patients receive gemcitabine (a nucleoside analog that inhibits DNA synthesis via ribonucleotide reductase inhibition and chain termination), mitomycin C (a bioreductive alkylating agent that crosslinks DNA and blocks DNA replication), and thalidomide (an immunomodulatory drug with anti-angiogenic effects, including reduced pro-angiogenic cytokine signaling). The scientific angle is repurposing older, widely available agents in a low-dose schedule that may exert anti-tumor and microenvironment/vascular pressure beyond classic “maximum tolerated dose” chemo logic, potentially improving feasibility for heavily pretreated patients. Because eligibility is broad across solid tumors, today’s care is typically tumor-specific sequencing of standard chemotherapy, targeted therapy when actionable alterations exist, and immunotherapy in responsive histologies, with best supportive care when options are exhausted; this trial tests whether a simple metronomic triplet can deliver meaningful disease control in that later-line setting.