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Ascorbate for Sarcoma
Mohammed Milhem, Iowa City, IA
Targeting 5 different conditionsAscorbatePhase < 1RecruitingLed by Mohammed Milhem, MBBSResearch Sponsored by Mohammed MilhemEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upevery 2 months for first 6 months, then every 3 months up to 2 years post treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Study Summary
This trial will enroll patients with metastatic sarcoma who have not responded to prior treatment.
Eligible Conditions
- Sarcoma
- Soft Tissue Sarcoma
- Bone Cancer
- Bone Sarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 2 months for first 6 months, then every 3 months up to 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months for first 6 months, then every 3 months up to 2 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation
Secondary outcome measures
Assess overall survival of patients with unresectable or metastatic soft tissue and bone sarcoma treated with high dose ascorbate when administered intravenously concurrently with gemcitabine
Neoplasms
Incidence of Adverse Events (AE) Per CTCAE 4.03
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gemcitabine + High-Dose AscorbateExperimental Treatment1 Intervention
Ascorabte is administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator. Treatment will be terminated with progression of disease. Disease will be assessed by CT of the chest, abdomen and pelvis or MRI of the lesion every 2 cycles for progression.
Find a site
Who is running the clinical trial?
Mohammed MilhemLead Sponsor
5 Previous Clinical Trials
99 Total Patients Enrolled
3 Trials studying Sarcoma
69 Patients Enrolled for Sarcoma
University of IowaOTHER
429 Previous Clinical Trials
870,414 Total Patients Enrolled
6 Trials studying Sarcoma
140 Patients Enrolled for Sarcoma
Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
99 Total Patients Enrolled
3 Trials studying Sarcoma
69 Patients Enrolled for Sarcoma
University of Iowa Adolescent and Young Adult (AYA) Cancer ProgramUNKNOWN
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Sarcoma
10 Patients Enrolled for Sarcoma
St. Baldrick's FoundationOTHER
18 Previous Clinical Trials
9,038 Total Patients Enrolled
2 Trials studying Sarcoma
35 Patients Enrolled for Sarcoma
Mohammed Milhem, MBBSPrincipal Investigator
University of Iowa Hospitals & Clinics3 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Sarcoma
25 Patients Enrolled for Sarcoma
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI