Trial Outcomes & Findings for Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma (NCT NCT00795665)

Last Updated: 2020-05-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Time from first day of treatment to the first observation of disease progression or death due to any cause (up to 7 years).

Results posted on

2020-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Bevacizumab and Carmustine bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU. carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab and Carmustine n=7 Participants bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU. carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time from first day of treatment to the first observation of disease progression or death due to any cause (up to 7 years).

Population: Procedure for fusing PET and MRI images could not be performed; as such the volumetrics of areas of tumor versus cerebral edema could not be analyzed or interpreted, therefore, no data can be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Response measured using MRI and PET with image fusion

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Measurements made by novel brain imaging

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Subjects will be assessed clinically for toxicity prior to, during, and after each infusion. NCI CTCAE 3.0 Common Terminology Criteria (CTC) for Adverse Events for toxicity and Adverse Event Reporting will be utilized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first day of treatment to time of death due to any cause (up to 7 years).

Outcome measures

Outcome data not reported

Adverse Events

Bevacizumab and Carmustine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bevacizumab and Carmustine n=7 participants at risk bevacizumab: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU. carmustine: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.
Metabolism and nutrition disorders Alanine aminotransferase increased	42.9% 3/7 • Up to 36 months.
Metabolism and nutrition disorders Alkaline phosphatase increased	28.6% 2/7 • Up to 36 months.
Metabolism and nutrition disorders Aspartate aminotransferase increased	28.6% 2/7 • Up to 36 months.
Renal and urinary disorders Cystitis	28.6% 2/7 • Up to 36 months.
Blood and lymphatic system disorders Edema limbs	28.6% 2/7 • Up to 36 months.
General disorders Fatigue	42.9% 3/7 • Up to 36 months.
General disorders Flu-like syndrome	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Hemoglobin	57.1% 4/7 • Up to 36 months.
Blood and lymphatic system disorders Hemoglobin decreased	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Hemorrhage - subconjunctival	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Hemorrhage nasal	14.3% 1/7 • Up to 36 months.
Metabolism and nutrition disorders Hyperbilirubinemia	14.3% 1/7 • Up to 36 months.
Skin and subcutaneous tissue disorders Hyperpigmentation	14.3% 1/7 • Up to 36 months.
Cardiac disorders Hypertension	28.6% 2/7 • Up to 36 months.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • Up to 36 months.
Metabolism and nutrition disorders Infection - Other (Ear Abscess)	14.3% 1/7 • Up to 36 months.
Metabolism and nutrition disorders Infection - Other (Urinary Tract, NOS)	14.3% 1/7 • Up to 36 months.
Nervous system disorders Ischemia cerebrovascular	14.3% 1/7 • Up to 36 months.
Musculoskeletal and connective tissue disorders Joint pain	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Leukocytes	57.1% 4/7 • Up to 36 months.
Blood and lymphatic system disorders Leukopenia	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Lymphopenia	57.1% 4/7 • Up to 36 months.
Gastrointestinal disorders Nausea	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Neutrophils	57.1% 4/7 • Up to 36 months.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Up to 36 months.
Musculoskeletal and connective tissue disorders Pain in extremity (arm)	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Platelet count decreased	14.3% 1/7 • Up to 36 months.
Blood and lymphatic system disorders Platelets	71.4% 5/7 • Up to 36 months.
Infections and infestations Pneumonia	14.3% 1/7 • Up to 36 months.
Metabolism and nutrition disorders Proteinuria	14.3% 1/7 • Up to 36 months.
Vascular disorders Thrombosis/thrombus/embolism	14.3% 1/7 • Up to 36 months.
Infections and infestations Urinary tract infection	28.6% 2/7 • Up to 36 months.

Additional Information

Analyst

University of California Davis

Phone: 916-734-8053

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place