Gemcitabine With Ascorbate Including Adolescents (NCT04877587) | Clinical Trial Compass
WithdrawnEarly Phase 1
Gemcitabine With Ascorbate Including Adolescents
Stopped: Unable to enroll
United States0Started 2023-01
Plain-language summary
The purpose of this research study is to see if a high dose of ascorbate (Vitamin C), in combination with the chemotherapy drug gemcitabine, is safe and effective in adolescents with locally advanced unresectable or metastatic soft tissue and bone sarcomas
Who can participate
Age range13 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients aged ≥ 13 years to 17 years
* ECOG Performance Status of ≤ 2
* Ability to provide written informed consent from patient guardian and informed assent from patient; obtained prior to participation in the study and any related procedures being performed
* Tolerate a 10g 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, adriamyc…
What they're measuring
1
Adverse Events as defined by CTCAE version 5.0
Timeframe: Adverse events will be followed for 4 weeks after the last pharmacologic ascorbate infusion
2
ORR as defined by RECIST 1.1 guidelines
Timeframe: For two years following completion of treatment