A Phase 2 Trial of High-Dose Ascorbate in Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT02344355|
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : May 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: Temozolomide Radiation: radiation therapy Drug: Ascorbic Acid||Phase 2|
Standard treatment for glioblastoma multiforme (GBM) involves maximum safe surgical resection followed by radiation combined with temozolomide (a chemotherapy pill you take by mouth). After radiation, patients receive additional cycles of temozolomide (adjuvant chemotherapy).
- receive high doses of intravenous (IV) ascorbate three times a week during the combined radiation and chemotherapy phase
- receive high doses of intravenous (IV) ascorbate twice a week during adjuvant chemotherapy (after radiation)
- complete health-related quality of life questionnaires pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and then every 3 months. In addition, patients will complete neurocognitive testing pre-radiation, 4 weeks into radiation, 4 weeks after radiation, and approximately 9 months after initiating radiation therapy.
The adjuvant chemotherapy portion of this study lasts for 6 months. After that is completed, participants will go back to standard therapy for their cancer. Participants will continue to have life-long follow-up for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacological Ascorbate Combined With Radiation and Temozolomide in Glioblastoma Multiforme: A Phase 2 Trial|
|Actual Study Start Date :||March 13, 2017|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||December 2023|
Experimental: ascorbate, radiation, temozolomide
Radiation therapy, oral temozolomide, and pharmacological ascorbate (ascorbic acid) infusions
Oral temozolomide and pharmacological ascorbate (ascorbic acid) infusions
oral temozolomide (75 mg/m2), given 7 days per week, for a maximum of 49 days during radiation therapy.
Starting 1 month after radiation therapy, additional temozolomide will be given as chemotherapy cycles. Each cycle is 28 days.
For the first cycle, temozolomide will be administered (150 mg/m2) once per day for 5 days.
If the subject tolerates the first cycle well, temozolomide will be prescribed at 200 mg/m2 for cycles 2 through 6. Each cycle is 28 days.
Radiation: radiation therapy
Conformal radiation administered daily, M-F, to a total dose of 61.2 Gray in 34 fractions.
Drug: Ascorbic Acid
Intravenous infusions of 87.5g of ascorbate administered three times weekly during radiation.
After radiation, ascorbate is administered twice weekly through the end of cycle 6 of temozolomide.
- Overall Survival (OS) [ Time Frame: monthly up to 5 years post treatment ]From radiation day 1 until date of death from any cause.
- Progression Free Survival (PFS) [ Time Frame: monthly up to 5 years post treatment ]From radiation day 1 to documented disease progression in MRI imaging as described by the RANO criteria
- Adverse Event Frequency [ Time Frame: monthly through 7 months post-radiation ]Categorize and quantify using the Common Terminology Criteria for Adverse Events (CTCAE) v. 4 from radiation day 1 through 7 months post-radiation.
- Health-related Quality of Life (HRQOL) [ Time Frame: monthly for 3 months, then every 3 months up to 5 years post treatment ]Measure health-related outcomes using the validated EORTC (European Organization for Research and Treatment of Cancer) questionnaires QLQ-C30 and BN-20.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344355
|Contact: Bryan G. Allen, MD, PhDemail@example.com|
|Contact: Joseph J Cullen, MDfirstname.lastname@example.org|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sandy Vollstedt, RN, BSN 319-353-7143 email@example.com|
|Contact: Heather Brown, RN, BAN 319-384-7912 firstname.lastname@example.org|
|Sub-Investigator: John M. Buatti, MD|
|Sub-Investigator: Joseph J. Cullen, MD|
|Sub-Investigator: Daniel Berg, MD|
|Sub-Investigator: Matthew Howard, MD|
|Sub-Investigator: Jeremy Greenlee, MD|
|Sub-Investigator: David Hasan, MD|
|Sub-Investigator: Patrick Hitchon, MD|
|Sub-Investigator: Varun Monga, MD|
|Sub-Investigator: Mark C. Smith, MD|
|Sub-Investigator: Carryn M. Anderson, MD|
|Sub-Investigator: Wenqing Sun, MD, PhD|
|Sub-Investigator: Douglas Spitz, PhD|
|Sub-Investigator: Mohammed Milhem, MBBA|
|Sub-Investigator: Garry R. Buettner, PhD|
|Principal Investigator:||Bryan G. Allen, MD, PhD||Assistant Professor, Department of Radiation Oncology, The University of Iowa|