Trial Outcomes & Findings for Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma (NCT NCT02168270)

Last Updated: 2023-11-24

Results Overview

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. Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

56 days

Results posted on

2023-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lack of Efficacy	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Ascorbic Acid, Temozolomide) n=4 Participants 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
Age, Continuous	42 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 56 days

Population: This study was terminated as subjects had disease progression so no subjects were evaluable.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 30 days after last administration of study medication

Population: This study was terminated after only 4 patients enrolled. Incidence rates of adverse event could not be describe by dose level.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 52 weeks

Population: No patients were analyzed as all experienced progressive disease after 2 cycles of treatment.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 52 weeks

Population: This outcome measure was not analyzed as all patients had progressive disease by 2 cycles of treatment.

The measurement of effect will be based on the Macdonald criteria

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Ascorbic Acid, Temozolomide)

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Ascorbic Acid, Temozolomide) n=4 participants at risk 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
General disorders Headache	25.0% 1/4 • Number of events 3 • Up to 52 weeks
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Up to 52 weeks
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 2 • Up to 52 weeks
Nervous system disorders Seizure	25.0% 1/4 • Number of events 2 • Up to 52 weeks
Musculoskeletal and connective tissue disorders Pain, Hip, back	25.0% 1/4 • Number of events 1 • Up to 52 weeks
General disorders Weakness	25.0% 1/4 • Number of events 1 • Up to 52 weeks
Renal and urinary disorders Urinary retention	25.0% 1/4 • Number of events 1 • Up to 52 weeks

Other adverse events

Other adverse events
Measure	Treatment (Ascorbic Acid, Temozolomide) n=4 participants at risk 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
Blood and lymphatic system disorders Lymphopenia	25.0% 1/4 • Number of events 2 • Up to 52 weeks
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 1 • Up to 52 weeks

Additional Information

Dr. Nicole Shonka

University of Nebraska Medical Center

Phone: 402-559-5166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place