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Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

NCT04634227 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

Conditions

  • Sarcoma
  • Soft Tissue Sarcoma
  • Unresectable Soft Tissue Sarcoma
  • Metastatic Bone Tumor
  • Bone Sarcoma

Interventions

DRUG

Ascorbate

Following 15g test dose, 75g administered 75g dose on days 1 and 2. Further doses of ascorbate will be determined by serum ascorbate levels measured by the end of the week to reach a target serum concentration between 20 -30 mM. Ascorbate doses will continue to be escalated until either the target serum concentration or maximum dose of 125 g is administered.

Sponsors & Collaborators

  • Mohammed Milhem, MBBS

    collaborator OTHER

  • University of Iowa

    lead OTHER

Principal Investigators

  • John Rieth, MD · University of Iowa Hospitals & Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2025-03-18
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04634227 on ClinicalTrials.gov