Study on Low-Dose Gemcitabine, Mitomycin C, and Thalidomide for Advanced Solid Tumors

Sponsor: Sarcoma Oncology Research Center, LLC

Sponsor score: 0

ClinicalTrials ID:NCT07671534

Provider View

This clinical trial is testing a combination of low-dose chemotherapy drugs, gemcitabine and mitomycin C, given through an IV, along with an oral medication, thalidomide, to see if they are safe and effective for treating advanced solid tumors.

Patient Parameters

Program Overview

This study is exploring the safety and effectiveness of a treatment using low doses of gemcitabine and mitomycin C, administered through an IV, and thalidomide taken by mouth, in patients with advanced solid tumors. About 40-60 participants will receive this treatment, which includes gemcitabine on specific days, mitomycin C every six weeks, and daily thalidomide for 15 days. Scans will be done every six weeks for the first six months and then every 12 weeks to monitor the cancer's response to the treatment.

Description

This Phase II study is designed to evaluate the safety and effectiveness of a low-dose treatment regimen for patients with advanced solid tumors. Participants will receive gemcitabine through an IV on days 1, 8, and 15, mitomycin C through an IV every six weeks, and thalidomide orally every day for 15 days. The study will involve regular CT or MRI scans every six weeks for the first six months and then every 12 weeks to track the cancer's progress. The treatment will continue for up to one year unless the cancer progresses or side effects become unacceptable.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic solid tumor.
  • Have previously received treatment for the cancer.
  • Have measurable disease according to specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least three months.
  • Have acceptable liver and kidney function based on specific blood tests.
  • Have adequate blood cell counts without recent support from growth factors or transfusions.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Understand the study and agree to sign informed consent.
  • Be willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria

  • Have untreated cancer that has spread to the brain or spinal cord.
  • Have cancer in the membranes surrounding the brain and spinal cord.
  • Have participated in another drug or device study within the last 14 days.
  • Have received chemotherapy within the last 14 days.
  • Be pregnant or breastfeeding.
  • Be unable or unwilling to follow the study protocol.
  • Have severe or uncontrolled medical conditions that make participation unsafe.
  • Have active hepatitis B or C infections.
  • Have a known history of HIV or AIDS.

Locations

FACILITYZIPCITYSTATE
Sarcoma Oncology Research Center / Cancer Center of Southern California90403Santa MonicaCalifornia

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