RecruitingPhase 2

Metronomic Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors

United States60 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. ECOG performance status ≤ 1
. Life expectancy of at least 3 months
. 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
. Acceptable hematologic status (without hematologic support e.g. growth factors or transfusion within 21 days of first dose of study agents): ANC ≥ 1500 cells/μL; Platelet count ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL; Normal PT, PTT, INR

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression Free Survival (PFS)

Timeframe: 12 months

Trial details

NCT IDNCT07671534

SponsorSarcoma Oncology Research Center, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06

Contact for this trial

Erlinda M. Gordon, MD

3105529999 egordon@sarcomaoncology.com

View on ClinicalTrials.gov More Solid Tumor Cancer trials