Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors
ConditionSolid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSarcoma Oncology Research Center, LLC
About this trial
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.
Eligibility criteria
Qualifiers
Male or Female ≥ 18 years of age
Pathologically confirmed diagnosis of locally advanced or metastatic solid tumor
Previously treated participants
Measurable disease by RECIST v1.1
Disqualifiers
Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.
Subjects with carcinomatous meningitis
Subjects who participated in an investigational drug or device study within 14 days prior to study entry
Subjects who had chemotherapy within 14 days prior to study entry
Trial design
Treatments tested in this trial
- Gemcitabine
- Mitomycin C
- Thalidomide
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov