Trial Outcomes & Findings for Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme (NCT NCT00006916)
NCT ID: NCT00006916
Last Updated: 2020-10-26
Results Overview
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
Results posted on
2020-10-26
Participant Flow
Participant milestones
| Measure |
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
|
|---|---|
|
Overall Study
Device not inserted
|
4
|
|
Overall Study
Complication of device insertion
|
1
|
Baseline Characteristics
Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Baseline characteristics by cohort
| Measure |
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
n=19 Participants
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Outcome measures
Outcome data not reported
Adverse Events
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
n=19 participants at risk
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
|
|---|---|
|
Vascular disorders
Thrombosis NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Blood and lymphatic system disorders
Infection (document
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Endocrine disorders
Endocrine-Other
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Coagulation disorde
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Leucopenia NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Convulsions NOS
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neurologic-Other
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Speech disorder NEC
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Syncope
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Oedema NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Other adverse events
| Measure |
Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir
n=19 participants at risk
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Haemoglobin decreased
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Earache
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Ear and labyrinth disorders
Hearing-Other
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Dry eye NEC
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Ocular-Other
|
21.1%
4/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Eye disorders
Vision blurred
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Gastrointestinal disorders
Vomiting NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Fatigue
|
57.9%
11/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Pain-Other
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
General disorders
Syndromes-Other
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Hepatobiliary disorders
Hepatic failure
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation NOS
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Injury, poisoning and procedural complications
Ecchymosis
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Alanine aminotransferase increas
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Aspartate aminotransferase incre
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Blood alkaline phosphatase NOS i
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Leucopenia NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Neutropenia
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Investigations
Platelet count decreased
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness NOS
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Amnesia NEC
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Convulsions NOS
|
26.3%
5/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Depressed level of consciousness
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Dizziness (exc vertigo)
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Headache NOS
|
26.3%
5/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Neurologic-Other
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.5%
2/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Speech disorder NEC
|
21.1%
4/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Nervous system disorders
Taste disturbance
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Anxiety NEC
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Confusion
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Psychiatric disorders
Depression NEC
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
31.6%
6/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Skin and subcutaneous tissue disorders
Skin-Other
|
5.3%
1/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
|
Vascular disorders
Oedema NOS
|
15.8%
3/19
Adverse events are reported for all subjects starting radiation therapy and/or bleomycin. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place