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ACTIVE NOT RECRUITING
NCT04634227
EARLY_PHASE1

Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

Sponsor: University of Iowa

View on ClinicalTrials.gov

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.

Official title: A Pilot Study of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2020-11-24

Completion Date

2026-12-31

Last Updated

2025-05-04

Healthy Volunteers

No

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.

Locations (1)

John

Iowa City, Iowa, United States