Trial Outcomes & Findings for Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344) (NCT NCT01925573)

NCT ID: NCT01925573

Last Updated: 2022-02-03

Results Overview

The ability to complete protocol treatment (i.e. tri-modality treatment) without undue acute toxicity as defined below * : \<40% rate of Grade 3 or higher nonhematologic toxicity. * : \<15% rate of Grade 4 or higher nonhematologic toxicity * : \<5% rate of Grade 4+ scalp dermatitis * : \<50% rate of Grade 2-3 scalp dermatitis Early stopping rules: Two or more Grade 2 or higher symptomatic CNS hemorrhages; Eight treatment-related Grade 3 or higher non hematologic or Grade 4 or higher hematologic toxicities.

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

6 months

Results posted on

2022-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Optune+RT+Bevacuzimab Part 1: Bevacizumab every 2 weeks plus Optune daily for 4 week cycles. Part 2: RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice. Part 3: Adjuvant Bevacizumab and Optune Optune(NOVOTTF-100A)
Overall Study STARTED	7
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Optune+RT+Bevacuzimab n=7 Participants Part 1: Bevacizumab every 2 weeks plus Optune daily for 4 week cycles. Part 2: RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice. Part 3: Adjuvant Bevacizumab and Optune Optune(NOVOTTF-100A)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants
Age, Continuous	59.7 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=93 Participants
Race/Ethnicity, Customized African American	1 Participants n=93 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Optune+RT+Bevacuzimab n=7 Participants Part 1: Bevacizumab every 2 weeks plus Optune daily for 4 week cycles. Part 2: RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice. Part 3: Adjuvant Bevacizumab and Optune Optune(NOVOTTF-100A)
Number of Participants With a Grade 3 or High Toxicity/Adverse Event (Primary Measure)	7 Participants

Adverse Events

Optune+RT+Bevacuzimab

Serious events: 5 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Optune+RT+Bevacuzimab n=7 participants at risk Part 1: Bevacizumab every 2 weeks plus Optune daily for 4 week cycles. Part 2: RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice. Part 3: Adjuvant Bevacizumab and Optune Optune(NOVOTTF-100A)
Vascular disorders Hypertension	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Muscle Weakness	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Encephalopathy	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Seizure	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Cranial- CN II Vision	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.

Other adverse events

Other adverse events
Measure	Optune+RT+Bevacuzimab n=7 participants at risk Part 1: Bevacizumab every 2 weeks plus Optune daily for 4 week cycles. Part 2: RT will begin post 3 round of Bevacizumab (hypofractionated radiotherapy: 30 Gy in 5 fractions or 35 Gy in 10 fractions) per physician choice. Part 3: Adjuvant Bevacizumab and Optune Optune(NOVOTTF-100A)
Ear and labyrinth disorders Tinnitus	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Blood and lymphatic system disorders Leukocytes (total WBC)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Blood and lymphatic system disorders Platelets	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Vascular disorders Hypertension	42.9% 3/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
General disorders Fatigue (asthenia, lethargy, malaise)	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify, __)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Pruritus/itching	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Chemoradiation	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Radiation	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Skin and subcutaneous tissue disorders Ulceration	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Metabolism and nutrition disorders Anorexia	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Gastrointestinal disorders Constipation	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Gastrointestinal disorders Taste alteration (dysgeusia)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Vascular disorders Hematoma	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
General disorders Edema: limb	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Investigations Alkaline phosphatase	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Investigations Bilirubin (hyperbilirubinemia)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Investigations Creatinine	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Extremity-lower (gait/walking)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Extremity-upper (function)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Facial	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Left-sided	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Ataxia (incoordination)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Cognitive disturbance	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Confusion	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Dizziness	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Memory impairment	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Mental status	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Psychiatric disorders Mood alteration - Agitation	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Psychiatric disorders Mood alteration - Anxiety	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Psychiatric disorders Mood alteration - Depression	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Psychiatric disorders Psychosis (hallucinations/delusions)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Seizure	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Speech impairment (e.g., dysphasia or aphasia)	28.6% 2/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Tremor	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Eye disorders Vision-blurred vision	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Pain - Back	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Nervous system disorders Pain - Head/headache	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Musculoskeletal and connective tissue disorders Pain - Joint	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
Renal and urinary disorders Urinary frequency/urgency	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.
General disorders Flu-like syndrome	14.3% 1/7 • AEs were evaluated per protocol during radiation and chemo, as well as during the follow-up period. Radiation and concurrent chemo lasted 6-7 weeks. Adjuvant chemo lasted 6-12 months after completion of radiation. Systematic assessment was done through regular physician assessments.

Additional Information

Caitlin Eggleston

University of Maryland Medical Center

Phone: 4103287586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place