A Phase 2 interventional study of motexafin gadolinium and 3-dimensional conformal radiation therapy in Untreated Childhood Brain Stem Glioma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2018-01-04.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's enrollment of 64 is above the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Diagnosis of intrinsic pontine glioma (brain stem glioma)
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
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.
Drug: motexafin gadolinium · Radiation: 3-dimensional conformal radiation therapy
Given IV
Also known as: gadolinium texaphyrin, Gd (III) Texaphryin, Gd-Tex, PCI-0120, Xcytrin
Undergo focal cranial radiotherapy
Also known as: 3D conformal radiation therapy, 3D-CRT
One Year Event-free Survival (EFS)
Percentage probability of being event-free at 1 year following enrollment.
Time frame: One year after enrollment.
Overall Survival (OS)
Percentage probability of being alive 1 year following enrollment.
Time frame: One year after enrollment.
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.
Time frame: One cycle of chemotherapy and radiation therapy; expected to be 42 days of treatment.
| Milestone | Radiation and Motexafin Gadolinium |
|---|---|
| Started | 64 |
| Completed | 50 |
| Not completed | 14 |
| Withdrew: Adverse event | 5 |
| Withdrew: Lack of efficacy | 2 |
| Withdrew: Physician decision | 2 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Ineligible for study | 2 |
Percentage probability of being event-free at 1 year following enrollment.
| percent probability | Radiation and Motexafin Gadolinium |
|---|---|
| One Year Event-free Survival (EFS) | 20 (11 to 31) |
Percentage probability of being alive 1 year following enrollment.
| percent probability | Radiation and Motexafin Gadolinium |
|---|---|
| Overall Survival (OS) | 53 (39 to 64) |
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.
| Participants | Radiation and Motexafin Gadolinium |
|---|---|
| The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity. | 31 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Radiation and Motexafin Gadolinium | — | 11/62 (17.7%) | 29/62 (46.8%) |
| Event | Radiation and Motexafin Gadolinium |
|---|---|
| Lymphocyte count decreasedInvestigations | 3/62 |
| FeverGeneral disorders | 2/62 |
| HydrocephalusNervous system disorders | 2/62 |
| Infections and infestations - Other, specifyInfections and infestations | 2/62 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 2/62 |
| Abducens nerve disorderNervous system disorders | 1/62 |
| Alanine aminotransferase increasedInvestigations | 1/62 |
| AnaphylaxisImmune system disorders | 1/62 |
| AtaxiaNervous system disorders | 1/62 |
| Catheter related infectionInfections and infestations | 1/62 |
| Event | Radiation and Motexafin Gadolinium |
|---|---|
| Lymphocyte count decreasedInvestigations | 7/62 |
| Alanine aminotransferase increasedInvestigations | 6/62 |
| HypertensionVascular disorders | 5/62 |
| HypophosphatemiaMetabolism and nutrition disorders | 3/62 |
| Peripheral motor neuropathyNervous system disorders | 3/62 |
| Weight gainInvestigations | 3/62 |
| AnorexiaMetabolism and nutrition disorders | 2/62 |
| AtaxiaNervous system disorders | 2/62 |
| HeadacheNervous system disorders | 2/62 |
| HyperglycemiaMetabolism and nutrition disorders | 2/62 |
| Age, Continuous(years) | Radiation and Motexafin Gadolinium |
|---|---|
| Mean | 6 (1 to 17) |
| Sex: Female, Male(Participants) | Radiation and Motexafin Gadolinium |
|---|---|
| Female | 34 |
| Male | 30 |
| Race (NIH/OMB)(Participants) | Radiation and Motexafin Gadolinium |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 42 |
| More than one race | 0 |
| Unknown or Not Reported | 9 |
| Ethnicity (NIH/OMB)(Participants) | Radiation and Motexafin Gadolinium |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 52 |
| Unknown or Not Reported | 5 |
| Region of Enrollment(participants) | Radiation and Motexafin Gadolinium |
|---|---|
| United States | 55 |
| Canada | 4 |
| Australia | 5 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)