Trial Outcomes & Findings for Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM (NCT NCT00004146)

NCT ID: NCT00004146

Last Updated: 2015-05-08

Results Overview

estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 55 participants
• Primary outcome timeframe: approximately 30 months
• Results posted on: 2015-05-08

Participant Flow

Between March and October of 2000 55 patients(pts) were accrued from outpatient clinics throughout ABTC(Adult Brain Tumor Consortium) consortium clinics

pts had to have confirmed GBM (Glioblastoma) and be untreated except for biopsy or surgery and corticosteroids.

Participant milestones

Measure	CAI With RT - Arm 1 CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboxyamidotriazole + RT in Treating Patients Newly Diagnosed Supratentorial GBM

Baseline characteristics by cohort

Measure	CAI With RT - Arm 1 n=55 Participants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Age, Customized	59 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	33 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	1 Participants n=5 Participants
Race (NIH/OMB) White	54 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
Karnofsky Performance Status Performance Status 100	9 participants n=5 Participants
Karnofsky Performance Status Performance Status 90	24 participants n=5 Participants
Karnofsky Performance Status Performance Status 80	10 participants n=5 Participants
Karnofsky Performance Status Performance Status 70	10 participants n=5 Participants
Karnofsky Performance Status Performance Status 60	2 participants n=5 Participants

PRIMARY outcome

Timeframe: approximately 30 months

Population: intent to treat pt population. time from histological diagnosis to death.

estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death

Outcome measures

Measure	CAI With RT - Arm 1 n=55 Participants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :	CAI With RT Without Enzyme Inducing Anticonvulsants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Overall Survival Rate	10.3 months Interval 8.5 to 12.8	—

PRIMARY outcome

Timeframe: pts were reviewed for toxicity while on treatement - median time of 2 months

Population: pts were treated for a median time of 2 months (23 days to 46 months). patients who experienced a grade 3 or higher event considered at least possibly related to CAI

patients who experienced a grade 3 or higher event considered at least possibly related to CAI

Outcome measures

Measure	CAI With RT - Arm 1 n=55 Participants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :	CAI With RT Without Enzyme Inducing Anticonvulsants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Toxicity of CAI When Combined With RT	16 participants	—

PRIMARY outcome

Timeframe: during treatment

Population: 50 subjects had PK samples for analysis

PK paramenters including steady state CAI concentrations with toxicity/or drug activity

Outcome measures

Measure	CAI With RT - Arm 1 n=42 Participants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :	CAI With RT Without Enzyme Inducing Anticonvulsants n=8 Participants CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Correlation Between PK CAI and Toxicity in This pt Population	1.3 ug/ml Standard Deviation 1.22	4.06 ug/ml Standard Deviation 1.5

Adverse Events

Arm 1

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1 n=55 participants at risk CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Investigations aspartate aminotransferase	1.8% 1/55 • Number of events 1 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Investigations Alanine aminotransferase	1.8% 1/55 • Number of events 1 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Blood and lymphatic system disorders febrile neutropenia	1.8% 1/55 • Number of events 1 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Eye disorders reversible vision loss	3.6% 2/55 • Number of events 2 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Gastrointestinal disorders hemorrhage-other	1.8% 1/55 • Number of events 1 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Metabolism and nutrition disorders hyperuricemia	1.8% 1/55 • Number of events 1 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)

Other adverse events

Measure	Arm 1 n=55 participants at risk CAI with RT carboxyamidotriazole : CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival radiation therapy :
Respiratory, thoracic and mediastinal disorders Dyspnea	3.6% 2/55 • Number of events 2 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
General disorders fatigue	9.1% 5/55 • Number of events 5 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)
Blood and lymphatic system disorders anemia	3.6% 2/55 • Number of events 2 • AE were collected while patients were on active treatment and for 30 days following treatment. pts were on active treatment for a median time of 2 months (23 days - 46 months)

Additional Information

Stuart A Grossman

Adult Brain Tumor Consortium

Phone: 410-955-3657

Email: jfisher@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60