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Trial record 32 of 228 for:    "Anaplastic oligodendroglioma"

Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma

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ClinicalTrials.gov Identifier: NCT02168270
Recruitment Status : Terminated
First Posted : June 20, 2014
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nicole Shonka, University of Nebraska

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Oligoastrocytoma
Glioblastoma
Gliosarcoma
Interventions Dietary Supplement: ascorbic acid
Drug: temozolomide
Other: quality-of-life assessment
Other: laboratory biomarker analysis
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Lack of Efficacy             4
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
42
(30 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Maximum Tolerated Dose of Ascorbic Acid in Combination With Temozolomide, Defined as the Highest Dose Tested Which Results in Dose Limiting Toxicity (DLT) in no More Than One of Six Evaluable Patients
Hide Description Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.
Time Frame 56 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This study was terminated as subjects had disease progression so no subjects were evalable.
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description:

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Incidence Rates of Adverse Events, Graded According to the NCI Common Toxicity Criteria for Adverse Events Version 4.0
Hide Description The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.
Time Frame Up to 30 days after last administration of study medication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This study was terminated after only 4 patients enrolled. Incidence rates of adverse event could not be describe by dose level.
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description:

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Changes in Serum Levels of Ascorbic Acid (Using HPLC With Coulometric Electrochemical Detection)
Hide Description Correlation of intracellular glutathione (in peripheral blood mononuclear cells) with ascorbic acid levels during therapy with ascorbic acid and temozolomide will be summarized using descriptive statistics to summarize changes over time.
Time Frame Baseline to up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed as all experienced progressive disease after 2 cycles of treatment.
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description:

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Using Radiologic Measurements for Tumor Response
Hide Description The measurement of effect will be based on the Macdonald criteria
Time Frame Up to 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not analyzed as all patients had progressive disease by 2 cycles of treatment.
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description:

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected from the time the first patient consented (6-30-14) until July 2015 when all subjects were off study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Ascorbic Acid, Temozolomide)
Hide Arm/Group Description

Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

ascorbic acid: Given IV

temozolomide: Given PO

quality-of-life assessment: Ancillary studies

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Treatment (Ascorbic Acid, Temozolomide)
Affected / at Risk (%)
Total   0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Ascorbic Acid, Temozolomide)
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Gastrointestinal disorders   
Vomiting * 1  1/4 (25.00%)  1
General disorders   
Headache * 1  1/4 (25.00%)  3
Weakness  1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
Hyponatremia * 1  1/4 (25.00%)  2
Musculoskeletal and connective tissue disorders   
Pain, Hip, back  1  1/4 (25.00%)  1
Nervous system disorders   
Seizure  1  1/4 (25.00%)  2
Renal and urinary disorders   
Urinary retention  1  1/4 (25.00%)  1
1
Term from vocabulary, NCI- CTCAE, v4.0
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Ascorbic Acid, Temozolomide)
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Blood and lymphatic system disorders   
Lymphopenia * 1 [1]  1/4 (25.00%)  2
Metabolism and nutrition disorders   
Hyponatremia  1  1/4 (25.00%)  1
1
Term from vocabulary, NCI- CTCAE, v4.0
*
Indicates events were collected by non-systematic assessment
[1]
low lymphocyte count
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Nicole Shonka
Organization: University of Nebraska Medical Center
Phone: 402-559-5166
Responsible Party: Nicole Shonka, University of Nebraska
ClinicalTrials.gov Identifier: NCT02168270     History of Changes
Other Study ID Numbers: 735-13
NCI-2014-01061 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
735-13 ( Other Identifier: University of Nebraska Medical Center )
P30CA036727 ( U.S. NIH Grant/Contract )
First Submitted: May 29, 2014
First Posted: June 20, 2014
Results First Submitted: January 25, 2018
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018