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Gemcitabine Plus Ascorbate for Sarcoma in Adults

NCT03468075 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-12-10

Study results available
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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 on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle

DRUG

Gemcitabine

Administered on Days 1, 8 and 15, after the infusion of ascorbate

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • St. Baldrick's Foundation

    collaborator OTHER

  • Mohammed Milhem, MBBS

    lead OTHER

Principal Investigators

  • Varun Monga, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2019-04-16
Completion
2020-10-19
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 NCT03468075 on ClinicalTrials.gov