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Gemcitabine With Ascorbate Including Adolescents

NCT04877587 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2023-02-22

No results posted yet for this study

Summary

The purpose of this research study is to see if a high dose of ascorbate (Vitamin C), in combination with the chemotherapy drug gemcitabine, is safe and effective in adolescents with locally advanced unresectable or metastatic soft tissue and bone sarcomas

Conditions

  • Soft Tissue Sarcoma
  • Bone Sarcoma
  • Unresectable Soft Tissue Sarcoma
  • Metastatic Bone Sarcoma
  • Metastatic Soft-tissue Sarcoma
  • Unresectable Bone Sarcoma

Interventions

DRUG

Ascorbate

A patient-individualized pharmacokinetically-guided dose escalation design will be used for Ascorbate. The goal of the within-patient dose escalation is to achieve a target plasma ascorbate level between 20mM and 30mM. The administered dose levels under consideration are listed below. Dose Level Ascorbate * 2 60 g/m2 IV Days (1,2,8,9,15,16) * 1 50 g/m2 IV Days (1,2,8,9,15,16) 0 (Starting dose) 40 g/m2 IV Days (1,2,8,9,15,16) * 1 30 g/m2 IV Days (1,2,8,9,15,16)

DRUG

Gemcitabine

Gemcitabine 900 mg/m2 given at a fixed dose rate of 10 mg/m2/min on D1, D8 and D15 to be given over 90 min every 28 days

Sponsors & Collaborators

  • David Dickens

    lead OTHER

Principal Investigators

  • David Dickens, MD, FAAP · University of Iowa Hospitals & Clinics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04877587 on ClinicalTrials.gov