Trial Outcomes & Findings for O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy (NCT NCT00436436)
NCT ID: NCT00436436
Last Updated: 2017-03-28
Results Overview
The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.
TERMINATED
PHASE2
12 participants
2-4 weeks
2017-03-28
Participant Flow
Participant milestones
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Overall Study
Progression
|
4
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
6
|
Baseline Characteristics
O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy
Baseline characteristics by cohort
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
n=12 Participants
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
52.03 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 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
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-4 weeksPopulation: No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.
The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2-4 weeksPopulation: Twelve patients were enrolled. The principal investigator wished to analyze the data but felt that there was insufficient data to report on and therefore closed the protocol when he left the National Cancer Institute (NCI).
The date of response will be the date the response is first radiographically documented following initiation of therapy (typically, the date of the actual imaging modality). Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 months and 4 daysHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE)v3.
Outcome measures
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
n=12 Participants
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Toxicity as Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v 3)
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.
Defined as the best tumor response recorded from the start of treatment until disease progression or withdrawal from the study. Complete response is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Partial response is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No disease does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.
Defined as the interval between the day of first administration of treatment and the first documentation of progressive disease or date of death. Progression is a 25% increase in the sum of products of all measurable lesions (or two largest lesions if too numerous) over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: No analysis was performed. The study was closed to accrual after the company chose to stop the development of the drug.
Defined as the interval between the day of first administration of treatment and the date of death.
Outcome measures
Outcome data not reported
Adverse Events
O6-benzylguanine & Temozolomide in Glioblastoma
Serious adverse events
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
n=12 participants at risk
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.7%
2/12 • Number of events 3 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
General disorders
Hypothermia
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
33.3%
4/12 • Number of events 6 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
2/12 • Number of events 5 • 18 months and 4 days
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Left-sided
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
16.7%
2/12 • Number of events 3 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Platelets
|
25.0%
3/12 • Number of events 7 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Nervous system disorders
Seizure
|
33.3%
4/12 • Number of events 6 • 18 months and 4 days
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
General disorders
Death due to progressive disease
|
50.0%
6/12 • Number of events 6 • 18 months and 4 days
|
Other adverse events
| Measure |
O6-benzylguanine & Temozolomide in Glioblastoma
n=12 participants at risk
Patients receive O6-benzylguanine intravenous over 1 hour and oral temozolomide once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
O6-benzylguanine
temozolomide
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
25.0%
3/12 • Number of events 4 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
16.7%
2/12 • Number of events 2 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other (Specify, leukopenia)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Nervous system disorders
Confusion
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
16.7%
2/12 • Number of events 2 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Edema: limb
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
41.7%
5/12 • Number of events 7 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
33.3%
4/12 • Number of events 5 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
41.7%
5/12 • Number of events 8 • 18 months and 4 days
|
|
Blood and lymphatic system disorders
Platelets
|
33.3%
4/12 • Number of events 8 • 18 months and 4 days
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • 18 months and 4 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place