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Trial record 32 of 230 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Ascorbic Acid, Temozolomide)

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


Participant Flow:   Overall Study
    Treatment (Ascorbic Acid, Temozolomide)
STARTED   4 
COMPLETED   0 
NOT COMPLETED   4 
Lack of Efficacy                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Ascorbic Acid, Temozolomide)

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


Baseline Measures
   Treatment (Ascorbic Acid, Temozolomide) 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Years]
Mean (Full Range)
 42 
 (30 to 64) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  50.0% 
Male      2  50.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   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   [ Time Frame: 56 days ]

2.  Primary:   Incidence Rates of Adverse Events, Graded According to the NCI Common Toxicity Criteria for Adverse Events Version 4.0   [ Time Frame: Up to 30 days after last administration of study medication ]

3.  Secondary:   Changes in Serum Levels of Ascorbic Acid (Using HPLC With Coulometric Electrochemical Detection)   [ Time Frame: Baseline to up to 52 weeks ]

4.  Secondary:   Using Radiologic Measurements for Tumor Response   [ Time Frame: Up to 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: nshonka@unmc.edu



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