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Vitamin
High-Dose Vitamin C with Radiation for Soft Tissue Sarcoma
Phase 1 & 2
Waitlist Available
Led By Varun Monga, MBBS
Research Sponsored by Mohammed Milhem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients do not have histologic subtypes: GIST, Desmoid, Ewing sarcoma, bone sarcomas, and Kaposi sarcoma.
Age ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment or start of treatment up to 2 years following end of treatment
Awards & highlights
Study Summary
This trial is testing whether high doses of ascorbate, taken with radiation therapy, can improve treatment for patients with advanced sarcomas.
Who is the study for?
Adults over 18 with locally advanced, high-grade soft tissue sarcomas that are large enough for radiation treatment and potentially surgery. Participants must be in good physical condition (ECOG ≤1) and not have certain sarcoma subtypes or other active cancers. They should not be pregnant, breastfeeding, or unwilling to use effective contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of high-dose ascorbate (vitamin C) given alongside preoperative radiotherapy for patients with resectable soft tissue sarcomas. It's a phase Ib/II study where all participants receive both treatments to see if this combination improves outcomes.See study design
What are the potential side effects?
Potential side effects may include reactions related to high doses of vitamin C such as gastrointestinal discomfort, increased risk of kidney stones, and possible interference with blood sugar levels in diabetic patients requiring insulin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not GIST, Desmoid, Ewing sarcoma, bone sarcomas, or Kaposi sarcoma.
Select...
I am 18 years old or older.
Select...
I can tolerate a test dose of vitamin C.
Select...
My tumor is at least 5 cm large and can be treated with radiation.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My sarcoma cannot be fully removed by surgery and needs radiotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within two years following end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within two years following end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants That Experienced Dose Limiting Toxicities (DLTs) Using CTCAE, Version 4.0
Number of Participants With Pathologic Tumor Necrosis ≥ 95% Following Concurrent Radiation Therapy and Ascorbate
Secondary outcome measures
Disease Progression as Measured by Time to Disease Progression (TTP)
Evaluate Diffusion Weighted Imaging Sequences
Labile Iron
+3 moreSide effects data
From 2016 Phase 1 & 2 trial • 5 Patients • NCT0175498740%
Elevated Creatinine
40%
Low Platelet count
20%
Dehydration
20%
Thrush
20%
Nosebleed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ascorbic Acid + Sorafenib
Sorafenib Alone
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase II CohortExperimental Treatment1 Intervention
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving intravenous (IV) ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
Group II: Phase I dose escalation cohortExperimental Treatment1 Intervention
Participants will receive radiation therapy over 5 weeks, during which time they will be receiving ascorbate infusions three times a week. Ascorbate infusions will be continued until the end of radiation therapy. Surgery will be performed 4-6 weeks from the end of radiation.
Find a Location
Who is running the clinical trial?
Mohammed MilhemLead Sponsor
6 Previous Clinical Trials
119 Total Patients Enrolled
Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
111 Total Patients Enrolled
University of IowaOTHER
446 Previous Clinical Trials
879,477 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I can tolerate a test dose of vitamin C.My cancer is not GIST, Desmoid, Ewing sarcoma, bone sarcomas, or Kaposi sarcoma.I am using two effective birth control methods during and for 3 months after treatment.I have brain metastasis but it has been treated.My blood tests show I might not be healthy enough for this study.I use insulin and check my blood sugar levels daily.I am taking medication that cannot be replaced, such as flecainide or methadone.My sarcoma has returned after surgery but I meet other study requirements.I have had painful kidney stones in the past year.I do not have any serious illnesses that would stop me from following the study's requirements.My tumor is at least 5 cm large and can be treated with radiation.I am on warfarin and cannot switch or refuse to switch medications.I have taken high-dose vitamin C as a treatment before.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have not had radiation over 20 Gy on my current sarcoma site.I have not had any other serious cancers in the last two years.I am fully active and can carry on all pre-disease activities without restriction.I have had skin cancer, in situ carcinoma, or low-risk prostate cancer.I am HIV-positive and/or have hepatitis B or C.My sarcoma cannot be fully removed by surgery and needs radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I dose escalation cohort
- Group 2: Phase II Cohort
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what ways is Ascorbate typically employed therapeutically?
"Ascorbate is frequently used to address a vitamin A deficiency, but it can also be beneficial for alleviating catarrh and reinforcing vitamins in the body."
Answered by AI
How many subjects are being monitored for this research project?
"Recruitment for this medical trial is currently inactive. The experiment was initially posted on June 27, 2019 and its most recent update occurred on October 11, 2022. Alternatively, there are 443 active studies recruiting sarcoma patients and 53 accepting enrollees with Ascorbate-related issues."
Answered by AI
What results are researchers expecting from this experiment?
"The primary purpose of this study, which spans from the start of treatment up to 4 weeks after the last ascorbate infusion, is to determine tumor response through pathological complete response rates (pCR). Secondary objectives include overall survival estimated using the Kaplan-Meier Method, an evaluation of overall response rate measured by RECIST 1.1 or a later tool for monitoring disease progression and skin toxicity levels compared with historical control data analyzed via binomial exact tests."
Answered by AI
Are there any open opportunities for individuals to join this experiment?
"Per the information found on clinicaltrials.gov, patient recruitment for this trial has concluded; its initial posting was June 27th 2019 and it's most recent edit occurred on October 11th 2022. Numerous alternative trials are still recruiting patients at present, as 496 other studies are actively seeking participants."
Answered by AI
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