Trial Outcomes & Findings for Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma (NCT NCT00387790)
NCT ID: NCT00387790
Last Updated: 2018-01-04
Results Overview
Percentage probability of being event-free at 1 year following enrollment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
One year after enrollment.
Results posted on
2018-01-04
Participant Flow
Participant milestones
| Measure |
Radiation and Motexafin Gadolinium
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Radiation and Motexafin Gadolinium
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Ineligible for study
|
2
|
Baseline Characteristics
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Baseline characteristics by cohort
| Measure |
Radiation and Motexafin Gadolinium
n=64 Participants
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Age, Continuous
|
6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year after enrollment.Population: Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome. The 2 patients who are ineligible were excluded from the Outcome Measure analysis.
Percentage probability of being event-free at 1 year following enrollment.
Outcome measures
| Measure |
Radiation and Motexafin Gadolinium
n=62 Participants
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
One Year Event-free Survival (EFS)
|
20 percent probability
Interval 11.0 to 31.0
|
SECONDARY outcome
Timeframe: One year after enrollment.Population: Only eligible patients are included therefore two patients were excluded from analysis.
Percentage probability of being alive 1 year following enrollment.
Outcome measures
| Measure |
Radiation and Motexafin Gadolinium
n=62 Participants
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Overall Survival (OS)
|
53 percent probability
Interval 39.0 to 64.0
|
SECONDARY outcome
Timeframe: One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.Population: Only eligible patients are included in the analysis, therefore two patients were excluded.
Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.
Outcome measures
| Measure |
Radiation and Motexafin Gadolinium
n=62 Participants
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
|
31 Participants
|
Adverse Events
Radiation and Motexafin Gadolinium
Serious events: 11 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiation and Motexafin Gadolinium
n=62 participants at risk
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Infections and infestations
Skin infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Weight loss
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Abducens nerve disorder
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Alanine aminotransferase increased
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Immune system disorders
Anaphylaxis
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Ataxia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Eye disorders
Extraocular muscle paresis
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Fever
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Hydrocephalus
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Vascular disorders
Hypotension
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Lymphocyte count decreased
|
4.8%
3/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Pain
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
Other adverse events
| Measure |
Radiation and Motexafin Gadolinium
n=62 participants at risk
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
motexafin gadolinium: Given IV
2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
9.7%
6/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Alkaline phosphatase increased
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Immune system disorders
Allergic reaction
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Immune system disorders
Anaphylaxis
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Ataxia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Bladder infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Catheter related infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Endocrine disorders
Cushingoid
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Dysphasia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Encephalopathy
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Ear and labyrinth disorders
External ear inflammation
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Facial nerve disorder
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Fatigue
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Glossopharyngeal nerve disorder
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Headache
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Hydrocephalus
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Vascular disorders
Hypertension
|
8.1%
5/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.8%
3/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Irritability
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Lung infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Lymphocyte count decreased
|
11.3%
7/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Otitis media
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
General disorders
Pain
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.8%
3/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Skin infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Infections and infestations
Upper respiratory infection
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Renal and urinary disorders
Urine discoloration
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
Weight gain
|
4.8%
3/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
|
Investigations
White blood cell decreased
|
3.2%
2/62
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 352-273-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60