Phase I Study of Neoadjuvant Therapy Imatinib Mesylate and Fampridine in KIT Mutant Gastrointestinal Stromal Tumor (GIST)
The goal of this clinical trial is to learn what dose of the drug fampridine can be given safely together with imatinib (Gleevec) in patients with gastrointestinal stromal tumor (GIST) with a DNA mutation in exon 11 of the KIT gene. The main questions this study aims to answer are: * What is the maximum dose of fampridine that can be given safely together with imatinib (Gleevec)? * Is the combination of the two drugs efficacious against the tumor? Participants will: * Take the drugs before tumor surgery (neoadjuvant treatment) for at least 2 months with the option to continue for a longer period of time if treatment seems safe and effective. * Visit the clinic at the scheduled appointments for checkups and tests.
• Provision of written informed consent prior to any screening procedures
• Age ≥ 18 years
• Having been pathologically confirmed to have a KIT exon 11 mutant gastrointestinal stromal tumor assessed for KIT variant mutations by next generation sequencing
• Treatment naïve gastrointestinal stromal tumor
• Described as a primary localized or locally advance gastrointestinal stromal tumor in any location that would benefit from neoadjuvant therapy before tumor surgical resection
• Has measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors v1.1.
• Has Eastern Cooperative Oncology Group Performance Status of 0-1
• Has adequate hematologic, hepatic, and renal function: Absolute Neutrophil Count ≥ 1.5 x 10\^9/L; Hemoglobin ≥ 11 g/dL; Platelets ≥ 100 x 10\^9/L; Serum total bilirubin \< 2.0 x upper limit of normal; Aspartate aminotransferase and alanine aminotransferase ≤ 5 x upper limit of normal; Plasma creatinine phosphokinase \< 1.5 x upper limit of normal; Serum creatinine ≤ 1.0 x upper limit of normal or calculated creatinine clearance ≥ 50ml/min based upon the Cockcroft-Gault Equation
• Life expectancy of ≥ 5 years
• Participants able to cause pregnancy agree to use an adequate method of contraception starting with the first dose of study therapy and for 120 days after the last dose