Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot) (NCT04634227) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)
United States30 participantsStarted 2020-11-24
Plain-language summary
This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female patients aged ≥ 18 years old
* ECOG Performance Status of ≤ 2
* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Tolerate a 15g ascorbate infusion (screening dose)
* Any patient with the diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except GIST and Kaposi's) from any site. A minimum of 1 prior chemotherapy regimen, including adjuvant or neo-adjuvant therapy for the treatment of sarcoma. Patients eligible for an anthracycline should have received a prior anthracycline containing regimen. Patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment. Patients with a diagnosis of liposarcoma should also have received eribulin if they received anthracycline-based therapy prior to eribulin. Patients with a diagnosis of myxoid liposarcoma should have received trabectedin. Patients with angiosarcoma should have received either taxol or docetaxel. Patients must have measurable disease defined as at least 1 lesion ≥ 1cm in the greatest dimension.
* Patients with metastatic bone sarcomas who have failed all available therapies that have demonstrated clinical benefit. Available therapies include but not limited to methotrexate, adriamycin and cisplatin for osteosarcoma and vincristine, adriamycin and Cytoxan, ifosfamide, etoposide (VAC/IE) for Ewing's sarcom…
What they're measuring
1
Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation