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Gemcitabine + Ascorbate for Sarcoma
Study Summary
This trial will enroll patients with metastatic sarcoma who have not responded to prior treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am a man and my partner uses two forms of birth control, including condoms.I can take care of myself but might not be able to do heavy physical work.I use insulin or check my blood sugar levels during ascorbate infusions.I haven't had cancer in the past 2 years, except for certain skin cancers or cervical cancer.I haven't had a heart attack or unstable chest pain in the last 6 months.I have advanced sarcoma, have had chemotherapy, and my tumor is at least 1cm big.I have treated brain metastases with no current signs of worsening and don't need steroids.I have G6PD deficiency.My hemoglobin level is below 9 g/dL, but I can receive a transfusion to qualify.My cancer has worsened after the last treatment or was already advanced when first diagnosed.My heart condition limits my physical activity.My kidney function is below normal levels.I can tolerate a vitamin C infusion.I have been treated with gemcitabine for cancer that has spread.My heart function is below normal after receiving doxorubicin.I am on warfarin and cannot switch to another blood thinner.I do not have any severe or uncontrolled medical conditions.I am not using any cancer treatments other than palliative radiation for non-targeted areas.My cancer has worsened after the last treatment or was already advanced when first diagnosed.My alkaline phosphatase levels are high, but I don't have bone metastases.My bone sarcoma has not responded to any effective treatments.I haven't had major blood vessel problems or surgeries in the last 6 months.I am 18 years old or older.I haven't taken chemotherapy or experimental drugs in the last 2 weeks and have recovered from any side effects.I am HIV positive but haven't been required to test for it at baseline.My brain metastases are treated and stable, with no current need for steroids.I have not had a stroke or mini-stroke in the last 6 months.I have advanced sarcoma, have had chemotherapy, and my tumor is at least 1cm big.I am taking medication that cannot be replaced, such as flecainide or methadone.I have had more than one painful kidney stone or visible stone on a CT scan in the last 6 months.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I am a woman who can have children and agree to use two forms of birth control, including a barrier method, during and for 3 months after the study.I am 18 years old or older.I can take care of myself and am up and about more than half of my waking hours.I can handle a vitamin C infusion without severe side effects.My bone cancer has not responded to any treatment, including methotrexate or adriamycin.
- Group 1: Gemcitabine + High-Dose Ascorbate
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants being actively recruited for this trial?
"Affirmative. Clinicaltrials.gov displays that the clinical trial, which was initially advertised on November 24th 2020, is currently inviting participants to join. The research requires 20 people from a single location."
Have investigators conducted any other experiments regarding Ascorbate?
"Currently, there are 493 Ascorbate-focused clinical trials with 141 Phase 3 experiments. Adelaide, South Australia houses numerous of these tests; however, other medical centres in a total of 25061 locations around the world are also running investigations into this compound's efficacy."
What conditions may Ascorbate be administered to alleviate?
"Small cell lung cancer (SCLC), head and neck carcinoma, as well as cervical cancers can all be managed with the help of Ascorbate."
What is the total capacity of participants for this clinical experiment?
"Affirmative. Data on clinicaltrials.gov shows that this medical trial, which was initially published on November 24th 2020 is actively accepting candidates. The study requires 20 patients who are willing to visit one location for participation."
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