Trial record 3 of 16 for:
mahajan
Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01469247
First received: November 4, 2011
Last updated: May 22, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to find a safe dose of radiation that can be given to patients with brainstem glioma who have already received radiation therapy.
You will receive photon radiation therapy. This type of radiation is similar to the radiation you have already had. Conformal radiotherapy or intensity modulated radiotherapy (IMRT) will be used to try to treat the tumor while affecting as little of the surrounding normal tissue as possible.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Cancer |
Radiation: Radiation Therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of Reirradiation of Recurrent or Progressive Brainstem Glioma |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Optimal Dose Level Among Three Radiation Therapy (RT) Dose Levels [ Time Frame: 1 month after radiation therapy ] [ Designated as safety issue: Yes ]Optimal dose level among three RT dose levels, defined in terms of the biologically equivalent dose (BED). The BED is given by the formula BED = (Total Dose)*(1 + d/3), denoting d = dose/fraction, with the constant 3 corresponding to brain tissue.
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiation Therapy
Starting dose of 24 Gy in 2 Gy fractions.
|
Radiation: Radiation Therapy
Starting Dose 24 Gy in 2 Gy fractions.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of diffuse intrinsic pontine glioma (DIPG) by magnetic resonance (MRI) imaging defined as tumor that has a pontine epicenter and is diffuse (tumor that involves the majority (>50%) of the brainstem) on T2 or Fluid attenuation inversion recovery (FLAIR) imaging rather than focal. Histologic confirmation is not required
- Radiation therapy to brain for Diffuse Intrinsic Pontine Glioma (DIPG) that was completed at least 10 months prior to planned reirradiation
- Clinical progression of symptoms with any radiographic progression on MRI within 21 days prior to registration (any progression in size or enhancement on MRI along with worsening symptoms, will be defined as progression prior to enrollment). Radiographic progression is defined as any increase in tumor size (in axial or sagittal images) or progressive contrast enhancement and abnormal T2/FLAIR signal by MRI.
- Signed informed consent by patient and/or parents or legal guardian
- Lansky/Karnofsky Performance Status score of 40-100
- Central nervous system function defined as not severely somnolent or comatose (central cortical neurotoxicity scale <Grade 3)
- Life expectancy of >/= 8 weeks
Exclusion Criteria:
- Prior radiation of greater than 60 Gy to >20% of brainstem.
- Patients with Neurofibromatosis 1 because the biologic behavior of their tumors may be more benign
- Asymptomatic patients because the primary goal of treatment is palliation of symptoms
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469247
Contacts
| Contact: Anita Mahajan, MD | 713-563-2300 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Anita Mahajan, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01469247 History of Changes |
| Other Study ID Numbers: | 2011-0804 |
| Study First Received: | November 4, 2011 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Brain cancer Recurrent or progressive brainstem glioma Diffuse Intrinsic Pontine Glioma DIPG |
Reirradiation ReRT Photon radiation therapy XRT |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioma Pontine Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Astrocytoma |
ClinicalTrials.gov processed this record on June 17, 2013