GEMINI: Phase II Study Using Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors
Sarcoma Oncology Research Center, LLC
Summary
This is an open label phase II study using metronomic low-dose gemcitabine and mitomycin c given intravenously, and thalidomide administered orally, for patients with advanced solid tumors.
Description
This Phase II open-label single-site study will evaluate the safety and efficacy of metronomic low dose (MLD) therapy with gemcitabine, mitomycin c, and thalidomide in approximately 40-60 patients with pathologically confirmed advanced solid tumors. Patients will receive gemcitabine 600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15; Mitomycin C 14 mg i.v. every 6 weeks; and Thalidomide 100 mg p.o. daily x 15 days. CT scan or MRI will be done every 6 weeks for 6 months and every 12 weeks thereafter until disease progression or unacceptable toxicity up to one year of treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or Female ≥ 18 years of age 2. Pathologically confirmed diagnosis of locally advanced or metastatic solid tumor 3. Previously treated participants 4. Measurable disease by RECIST v1.1 5. ECOG performance status ≤ 1 6. Life expectancy of at least 3 months 7. Acceptable liver function: Bilirubin ≤ 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \< 3.0 ULN); AST (SGOT), ALT (SGPT) and alkaline phosphatase ≤ 3 x ULN (\< 5 x ULN if liver metastases); Acceptable renal function: Creatinine \< 1.5 times ULN…
Interventions
- DrugGemcitabine
600 mg/m2 (Max: 1000 mg) i.v. on D1, D8, D15
- DrugMitomycin C
Mitomycin C 14 mg i.v. every 6 weeks
- DrugThalidomide
Thalidomide 100 mg daily x 15 days
Location
- Sarcoma Oncology Research Center / Cancer Center of Southern CaliforniaSanta Monica, California