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Anti-metabolites

Ascorbate for Bone Sarcoma

Phase < 1
Waitlist Available
Led By William Terry, MD
Research Sponsored by William Terry
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients aged ≥ 13 years to 17 years
ECOG Performance Status of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse events will be followed for 4 weeks after the last pharmacologic ascorbate infusion
Awards & highlights

Study Summary

This trial is testing if a high dose of Vitamin C, given with the chemotherapy drug gemcitabine, is safe and effective for teens with sarcomas that have spread or can't be removed with surgery.

Eligible Conditions
  • Bone Sarcoma
  • Soft Tissue Sarcoma
  • Bone Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse events will be followed for 4 weeks after the last pharmacologic ascorbate infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and adverse events will be followed for 4 weeks after the last pharmacologic ascorbate infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events as defined by CTCAE version 5.0
ORR as defined by RECIST 1.1 guidelines
Secondary outcome measures
OS defined as the time from first day of study treatment to death due to any cause
PFS defined by RECIST 1.1 guidelines

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ascorbate in combination with GemcitabineExperimental Treatment2 Interventions
The study will begin with a safety run-in. A patient-individualized pharmacokinetically-guided dose escalation design will be used for Ascorbate. Gemcitabine is administered following standard fixed dose infusion practice adopted at The University of Iowa Hospitals & Clinics. Ascorbate is infused prior to gemcitabine. Cycles are 28 days. Patients will be treated for a total of 6 cycles and assessed every 2 cycles for disease response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

William TerryLead Sponsor
David DickensLead Sponsor
William Terry, MDPrincipal InvestigatorUniversity of Iowa Hospitals & Clinics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any other investigations into the efficacy of Ascorbate?

"As of now, 495 clinical trials related to Ascorbate are ongoing with 142 in their final phase. Although the majority of these studies occur within Woolloongabba, Queensland, a total 25057 sites across the world are hosting investigations for this therapy."

Answered by AI

Are there still vacancies open for participants in this research trial?

"Clinicaltrials.gov data confirms that this study is no longer actively enrolling patients, as the last update was done on September 16th 2022. However, there are other medical trials currently in progress that require participants - 994 to be exact."

Answered by AI

Does the eligibility criteria for this experiment encompass individuals under forty years of age?

"Per the trial's stated requirements, eligible candidates will be aged between 13 and 17 years old. The database lists 234 studies with participants under 18 and 862 for those over 65."

Answered by AI

To whom is it possible to apply for this research initiative?

"This medical experiment is looking for 20 minors diagnosed with soft tissue sarcoma (STS) between the ages of 13 and 17. To be eligible, candidates must have had prior chemotherapy treatments such as methotrexate or adriamycin; should not display any residual toxicity from preceding therapies; possess measurable disease that spans at least 1 cm in length; and achieve an Eastern Cooperative Oncology Group Performance Status score of 2 or lower."

Answered by AI

Are there any limitations on the number of people permitted to participate in this clinical experiment?

"This clinical study is no longer accepting participants. It was initially posted on January 1st 2023 and the last update occurred on September 16th 2022. If you are still seeking trials, there currently exist 499 actively recruiting patients with soft tissue sarcomas (STS) and 495 studies for Ascorbate that are open to enrollment."

Answered by AI

To what medical ailments is Ascorbate commonly administered?

"Ascorbate is popularly used to address small cell lung cancer (sclc) but it can also be applied therapeutically in the treatment of head and neck carcinoma, cervical cancers, and catarrh."

Answered by AI
~0 spots leftby May 2025