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Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

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ClinicalTrials.gov Identifier: NCT00387790
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : February 5, 2014
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Untreated Childhood Brain Stem Glioma
Interventions Drug: motexafin gadolinium
Radiation: 3-dimensional conformal radiation therapy
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description

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

Period Title: Overall Study
Started 64
Completed 50
Not Completed 14
Reason Not Completed
Adverse Event             5
Lack of Efficacy             2
Physician Decision             2
Withdrawal by Subject             3
Ineligible for study             2
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description

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 Number of Baseline Participants 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 64 participants
6
(1 to 17)
[1]
Measure Description: Patients found not to meet the eligibility requirements are excluded from the age baseline measure.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Female
34
  53.1%
Male
30
  46.9%
[1]
Measure Description: Patients found not to meet the eligibility requirements were not included in the gender baseline measure.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
American Indian or Alaska Native
1
   1.6%
Asian
1
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  17.2%
White
42
  65.6%
More than one race
0
   0.0%
Unknown or Not Reported
9
  14.1%
[1]
Measure Description: Patients found not to meet the eligibility requirements are excluded from the race baseline measure.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants
Hispanic or Latino
7
  10.9%
Not Hispanic or Latino
52
  81.3%
Unknown or Not Reported
5
   7.8%
[1]
Measure Description: Patients found not to meet the eligibility requirements are excluded from the ethnicity baseline measure.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 64 participants
United States 55
Canada 4
Australia 5
[1]
Measure Description: Patients found not to meet the eligibility requirements are excluded from the region baseline measure.
1.Primary Outcome
Title One Year Event-free Survival (EFS)
Hide Description Percentage probability of being event-free at 1 year following enrollment.
Time Frame One year after enrollment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description:

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 Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
20
(11 to 31)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Percentage probability of being alive 1 year following enrollment.
Time Frame One year after enrollment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included therefore two patients were excluded from analysis.
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description:

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 Number of Participants Analyzed 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent probability
53
(39 to 64)
3.Secondary Outcome
Title The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity.
Hide Description 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.
Time Frame One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients are included in the analysis, therefore two patients were excluded.
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description:

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 Number of Participants Analyzed 62
Measure Type: Count of Participants
Unit of Measure: Participants
31
  50.0%
Time Frame [Not Specified]
Adverse Event Reporting Description Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
 
Arm/Group Title Radiation and Motexafin Gadolinium
Hide Arm/Group Description

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

All-Cause Mortality
Radiation and Motexafin Gadolinium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radiation and Motexafin Gadolinium
Affected / at Risk (%)
Total   11/62 (17.74%) 
Eye disorders   
Extraocular muscle paresis  1/62 (1.61%) 
General disorders   
Fever  2/62 (3.23%) 
Pain  1/62 (1.61%) 
Immune system disorders   
Anaphylaxis  1/62 (1.61%) 
Infections and infestations   
Catheter related infection  1/62 (1.61%) 
Infections and infestations - Other, specify  2/62 (3.23%) 
Skin infection  1/62 (1.61%) 
Investigations   
Alanine aminotransferase increased  1/62 (1.61%) 
Lymphocyte count decreased  3/62 (4.84%) 
Weight loss  1/62 (1.61%) 
Nervous system disorders   
Abducens nerve disorder  1/62 (1.61%) 
Ataxia  1/62 (1.61%) 
Hydrocephalus  2/62 (3.23%) 
Peripheral motor neuropathy  1/62 (1.61%) 
Peripheral sensory neuropathy  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1/62 (1.61%) 
Hypoxia  1/62 (1.61%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  2/62 (3.23%) 
Vascular disorders   
Hypotension  1/62 (1.61%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiation and Motexafin Gadolinium
Affected / at Risk (%)
Total   29/62 (46.77%) 
Ear and labyrinth disorders   
External ear inflammation  1/62 (1.61%) 
Endocrine disorders   
Cushingoid  1/62 (1.61%) 
Gastrointestinal disorders   
Constipation  1/62 (1.61%) 
Diarrhea  1/62 (1.61%) 
Dysphagia  1/62 (1.61%) 
Ileus  1/62 (1.61%) 
Mucositis oral  1/62 (1.61%) 
Vomiting  1/62 (1.61%) 
General disorders   
Fatigue  1/62 (1.61%) 
Irritability  1/62 (1.61%) 
Pain  1/62 (1.61%) 
Immune system disorders   
Allergic reaction  1/62 (1.61%) 
Anaphylaxis  1/62 (1.61%) 
Infections and infestations   
Bladder infection  1/62 (1.61%) 
Catheter related infection  1/62 (1.61%) 
Infections and infestations - Other, specify  1/62 (1.61%) 
Lung infection  1/62 (1.61%) 
Otitis media  2/62 (3.23%) 
Skin infection  1/62 (1.61%) 
Upper respiratory infection  1/62 (1.61%) 
Investigations   
Alanine aminotransferase increased  6/62 (9.68%) 
Alkaline phosphatase increased  1/62 (1.61%) 
Aspartate aminotransferase increased  1/62 (1.61%) 
Lymphocyte count decreased  7/62 (11.29%) 
Neutrophil count decreased  1/62 (1.61%) 
Weight gain  3/62 (4.84%) 
White blood cell decreased  2/62 (3.23%) 
Metabolism and nutrition disorders   
Anorexia  2/62 (3.23%) 
Hyperglycemia  2/62 (3.23%) 
Hypermagnesemia  2/62 (3.23%) 
Hyperuricemia  1/62 (1.61%) 
Hypoalbuminemia  2/62 (3.23%) 
Hypocalcemia  1/62 (1.61%) 
Hypoglycemia  1/62 (1.61%) 
Hypokalemia  2/62 (3.23%) 
Hyponatremia  1/62 (1.61%) 
Hypophosphatemia  3/62 (4.84%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity  2/62 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1/62 (1.61%) 
Nervous system disorders   
Ataxia  2/62 (3.23%) 
Dysphasia  1/62 (1.61%) 
Encephalopathy  1/62 (1.61%) 
Facial nerve disorder  1/62 (1.61%) 
Glossopharyngeal nerve disorder  1/62 (1.61%) 
Headache  2/62 (3.23%) 
Hydrocephalus  1/62 (1.61%) 
Peripheral motor neuropathy  3/62 (4.84%) 
Peripheral sensory neuropathy  2/62 (3.23%) 
Renal and urinary disorders   
Urine discoloration  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1/62 (1.61%) 
Apnea  1/62 (1.61%) 
Skin and subcutaneous tissue disorders   
Alopecia  1/62 (1.61%) 
Palmar-plantar erythrodysesthesia syndrome  2/62 (3.23%) 
Pruritus  1/62 (1.61%) 
Rash maculo-papular  1/62 (1.61%) 
Vascular disorders   
Hypertension  5/62 (8.06%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0558
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387790     History of Changes
Other Study ID Numbers: NCI-2012-01829
NCI-2012-01829 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000504107
COG-ACNS0222
ACNS0222 ( Other Identifier: Children's Oncology Group )
ACNS0222 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: October 12, 2006
First Posted: October 13, 2006
Results First Submitted: December 18, 2013
Results First Posted: February 5, 2014
Last Update Posted: January 4, 2018