Trial Outcomes & Findings for Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma (NCT NCT02395692)
NCT ID: NCT02395692
Last Updated: 2019-04-04
Results Overview
To test the hypothesis that the combination treatment of temozolomide and methoxyamine will achieve 30% radiographic response rate (partial response + complete response) in patients with first recurrence of glioblastoma. Per Response Assessment in Neuro-Oncology (RANO) Criteria: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to at least 2 years
Results posted on
2019-04-04
Participant Flow
1 subject withdrew before start of study
Participant milestones
| Measure |
Arm1 Methoxyamine &Temozolomide (Bevacizumab-naïve)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-naive
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine & Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
0
|
|
Overall Study
COMPLETED
|
19
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Treatment (Methoxyamine, Temozolomide)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|
|
Age, Customized
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
|
80 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to at least 2 yearsPopulation: This was a 2 stage design study. if there were less than 2 responders in first 19 subjects, study would terminate and Arm2 would not accrue any subjects.
To test the hypothesis that the combination treatment of temozolomide and methoxyamine will achieve 30% radiographic response rate (partial response + complete response) in patients with first recurrence of glioblastoma. Per Response Assessment in Neuro-Oncology (RANO) Criteria: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Objective Response as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria (Arm 1 and Arm 2)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days following the last dose of study drugPopulation: Patients diagnosed with glioblastoma
Number of participants who experience adverse events graded 3 or higher as defined by National Cancer Institute CTCAE v4.0.
Outcome measures
| Measure |
Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Toxicity as Assessed by Number of Participants Who Experienced Adverse Events
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to at least 2 yearsWill be analyzed using standard descriptive statistical methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Progression-free Survival
|
2 months
Interval 1.8 to 3.6
|
—
|
SECONDARY outcome
Timeframe: 6 monthsWill be analyzed using standard descriptive statistical methods.
Outcome measures
| Measure |
Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Progression-free Survival at 6 Months
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to at least 2 yearsWill be analyzed using standard descriptive statistical methods.
Outcome measures
| Measure |
Arm1 Methoxyamine&Temozolomide (Bevacizumab-naïve)
n=19 Participants
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. (Bevacizumab-naïve)
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
Arm2 Methoxyamine&Temozolomide (Bevacizumab-refractory)
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Bevacizumab-refractory
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|---|
|
Overall Survival
|
11 months
Interval 8.0 to 18.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Data was not collected to assess this outcome measure.
MPG, topo II-alpha, and MGMT levels will be correlated with response, PFS, and overall survival. Will be analyzed using standard descriptive statistical methods.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Methoxyamine, Temozolomide)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Methoxyamine, Temozolomide)
n=19 participants at risk
Patients receive methoxyamine PO QD and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Methoxyamine: Given PO
Temozolomide: Given PO
|
|---|---|
|
Investigations
Alanine Aminotransferase increased
|
36.8%
7/19 • Number of events 7 • Day 1 and 30 days after the last dose of the study drug
|
|
Blood and lymphatic system disorders
Anemia
|
89.5%
17/19 • Number of events 42 • Day 1 and 30 days after the last dose of the study drug
|
|
Metabolism and nutrition disorders
anorexia
|
21.1%
4/19 • Number of events 4 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Aspartate aminotransferase increased
|
26.3%
5/19 • Number of events 5 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Blood bilirubin increased
|
47.4%
9/19 • Number of events 9 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
Constipation
|
47.4%
9/19 • Number of events 10 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
diarrhea
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Dizziness
|
15.8%
3/19 • Number of events 3 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Dysphasia
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
General disorders
fatigue
|
36.8%
7/19 • Number of events 11 • Day 1 and 30 days after the last dose of the study drug
|
|
General disorders
Fever
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Headache
|
21.1%
4/19 • Number of events 5 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Lymphocyte count decreased
|
10.5%
2/19 • Number of events 4 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
Nausea
|
36.8%
7/19 • Number of events 8 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Neutrophil count decreased
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Platelet count decreased
|
21.1%
4/19 • Number of events 9 • Day 1 and 30 days after the last dose of the study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
White blood cell decreased
|
52.6%
10/19 • Number of events 21 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Ataxia
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Cholesterol high
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Cognitive disturbance
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Endocrine disorders
Cushingoid
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
General disorders
Gait disturbance
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Investigations - Other, TRIGLYCERIDES HIGH
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Alkaline phosphatase increased
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
INCREASED BOWEL MOVEMENTS
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
COLON POLYP
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Nervous system disorders - Other, EXTREMELY HOT SENSATION
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Nervous system disorders - Other, Vasogenic Edema
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, SORE IN GROIN AREA
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Nervous system disorders
Stroke
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Investigations
Weight Gain
|
5.3%
1/19 • Number of events 1 • Day 1 and 30 days after the last dose of the study drug
|
|
Renal and urinary disorders
Urine discoloration
|
5.3%
1/19 • Number of events 2 • Day 1 and 30 days after the last dose of the study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60