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A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

NCT01752491 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-12-20

No results posted yet for this study

Summary

This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).

Conditions

Interventions

DRUG

Ascorbate

Intravenous infusion of high-dose ascorbate

DRUG

Temozolomide

Oral chemotherapeutic

RADIATION

Radiation therapy

External beam radiation therapy

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • Joseph J. Cullen, MD, FACS

    lead OTHER

Principal Investigators

  • John M. Buatti, MD · Department of Radiation Oncology, The University of Iowa

  • Joseph J Cullen, MD · Professor of Surgery, The University of Iowa

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2015-11-30
Completion
2019-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01752491 on ClinicalTrials.gov