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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma).
SECONDARY OBJECTIVES:
I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients.
II. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients.
OUTLINE: This is a multicenter study.
Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years and then periodically thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| motexafin gadolinium | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| One Year Event-free Survival (EFS) | Percentage probability of being event-free at 1 year following enrollment. | One year after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Percentage probability of being alive 1 year following enrollment. | One year after enrollment. |
| The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. |
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Inclusion Criteria:
Diagnosis of intrinsic pontine glioma (brain stem glioma)
Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤ 16 years)
Life expectancy ≥ 8 weeks
Absolute neutrophil count ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³ (transfusion independent)
Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine normal for age/gender (0.4-1.7 mg/dL)
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT < 1.5 times ULN
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
No biliary obstruction
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior definitive therapy for this specific tumor
No prior cranial radiotherapy
Concurrent steroids and anticonvulsants allowed
No concurrent proton therapy
No concurrent intensity-modulated radiotherapy
No concurrent anticancer chemotherapy
No concurrent immunomodulating agents
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Bradley | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients found not to meet the eligibility requirements are excluded from the age baseline measure. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | One Year Event-free Survival (EFS) | Percentage probability of being event-free at 1 year following enrollment. | 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. | Posted | Number | 95% Confidence Interval | percent probability | One year after enrollment. |
|
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Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abducens nerve disorder | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 352-273-0558 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| C437683 | motexafin gadolinium |
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 3-dimensional conformal radiation therapy | Radiation | Undergo focal cranial radiotherapy |
|
|
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.
| One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment. |
| Withdrawal by Subject |
|
| Ineligible for study |
|
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Patients found not to meet the eligibility requirements were not included in the gender baseline measure. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Patients found not to meet the eligibility requirements are excluded from the race baseline measure. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Patients found not to meet the eligibility requirements are excluded from the ethnicity baseline measure. | Count of Participants | Participants |
|
| Region of Enrollment | Patients found not to meet the eligibility requirements are excluded from the region baseline measure. | Number | participants |
|
|
|
| Secondary | Overall Survival (OS) | Percentage probability of being alive 1 year following enrollment. | Only eligible patients are included therefore two patients were excluded from analysis. | Posted | Number | 95% Confidence Interval | percent probability | One year after enrollment. |
|
|
|
| Secondary | The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. | 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. | Only eligible patients are included in the analysis, therefore two patients were excluded. | Posted | Count of Participants | Participants | One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment. |
|
|
|
| 11 |
| 62 |
| 29 |
| 62 |
| Alanine aminotransferase increased | Investigations |
|
| Anaphylaxis | Immune system disorders |
|
| Ataxia | Nervous system disorders |
|
| Catheter related infection | Infections and infestations |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Extraocular muscle paresis | Eye disorders |
|
| Fever | General disorders |
|
| Hydrocephalus | Nervous system disorders |
|
| Hypotension | Vascular disorders |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
|
| Infections and infestations - Other, specify | Infections and infestations |
|
| Lymphocyte count decreased | Investigations |
|
| Pain | General disorders |
|
| Peripheral motor neuropathy | Nervous system disorders |
|
| Peripheral sensory neuropathy | Nervous system disorders |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders |
|
| Skin infection | Infections and infestations |
|
| Weight loss | Investigations |
|
| Alkaline phosphatase increased | Investigations |
|
| Allergic reaction | Immune system disorders |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders |
|
| Alopecia | Skin and subcutaneous tissue disorders |
|
| Anaphylaxis | Immune system disorders |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Apnea | Respiratory, thoracic and mediastinal disorders |
|
| Aspartate aminotransferase increased | Investigations |
|
| Ataxia | Nervous system disorders |
|
| Bladder infection | Infections and infestations |
|
| Catheter related infection | Infections and infestations |
|
| Constipation | Gastrointestinal disorders |
|
| Cushingoid | Endocrine disorders |
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| Diarrhea | Gastrointestinal disorders |
|
| Dysphagia | Gastrointestinal disorders |
|
| Dysphasia | Nervous system disorders |
|
| Encephalopathy | Nervous system disorders |
|
| External ear inflammation | Ear and labyrinth disorders |
|
| Facial nerve disorder | Nervous system disorders |
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| Fatigue | General disorders |
|
| Glossopharyngeal nerve disorder | Nervous system disorders |
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| Headache | Nervous system disorders |
|
| Hydrocephalus | Nervous system disorders |
|
| Hyperglycemia | Metabolism and nutrition disorders |
|
| Hypermagnesemia | Metabolism and nutrition disorders |
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| Hypertension | Vascular disorders |
|
| Hyperuricemia | Metabolism and nutrition disorders |
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| Hypoalbuminemia | Metabolism and nutrition disorders |
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| Hypocalcemia | Metabolism and nutrition disorders |
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| Hypoglycemia | Metabolism and nutrition disorders |
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| Hypokalemia | Metabolism and nutrition disorders |
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| Hyponatremia | Metabolism and nutrition disorders |
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| Hypophosphatemia | Metabolism and nutrition disorders |
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| Ileus | Gastrointestinal disorders |
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| Infections and infestations - Other, specify | Infections and infestations |
|
| Irritability | General disorders |
|
| Lung infection | Infections and infestations |
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| Lymphocyte count decreased | Investigations |
|
| Mucositis oral | Gastrointestinal disorders |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Neutrophil count decreased | Investigations |
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| Otitis media | Infections and infestations |
|
| Pain | General disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders |
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| Peripheral motor neuropathy | Nervous system disorders |
|
| Peripheral sensory neuropathy | Nervous system disorders |
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| Pruritus | Skin and subcutaneous tissue disorders |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders |
|
| Skin infection | Infections and infestations |
|
| Upper respiratory infection | Infections and infestations |
|
| Urine discoloration | Renal and urinary disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Weight gain | Investigations |
|
| White blood cell decreased | Investigations |
|
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