A Study of Capecitabine [Xeloda] and Concomitant Radiation Therapy in Children and Adolescent Patients With Newly Diagnosed Brainstem Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Collaborator:
Pediatric Brain Tumor Consortium
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01118377
First received: April 15, 2010
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This open-label study will evaluate the progression-free survival, safety and pharmacokinetics of capecitabine [Xeloda] rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. Xeloda will be administered 650 mg/m2 orally twice daily during radiation phase (courses 1-3) followed by a two-weeks break and Xeloda will be administered 1250 mg/m2 during post radiation (courses 4-6). During each course, Xeloda will be administered for 14 consecutive days followed by a 7-days rest period. Dose can be adjusted according to toxicity and body surface area. The anticipated time on study drug is 18 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioma |
Drug: capecitabine [Xeloda] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Phase II Study Evaluating the Safety and Efficacy of the Addition of Capecitabine (Xeloda®) to Radiation Therapy Compared to Historical Control, in Children With Newly-diagnosed Non-disseminated Intrinsic Diffuse Brain Stem Gliomas. |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Progression-free survival: MRI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival distribution: OS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Safety Profile: Adverse Events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Pharmacokinetics of capecitabine [Xeloda] and its metabolites [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Safety: Laboratory Parameters [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: capecitabine |
Drug: capecitabine [Xeloda]
capecitabine [Xeloda] 650 mg/m2 orally twice daily on weeks 1-9 (courses 1-3) during radiation phase and 1250 mg/m2 orally twice daily weeks 12, 13, 15, 16, 18, 19 (courses 4-6) during post radiation phase. During each course capecitabine will be administered for 14 consecutive days followed by a 7-days rest period.
|
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- pediatric and adolescent patients >/=3 to <18 years of age
- patients must have a newly diagnosed non-disseminated intrinsic infiltrating brainstem glioma
- Karnofsky Performance Scale (if >16 years of age) or Lansky Performance Score (if </=16 years of age) >/= 50% assessed within two weeks prior to registration to study
- patients must not have received any prior chemotherapy or bone marrow transplant for the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
- adequate organ function
Exclusion Criteria:
- patients receiving any other anticancer or experimental drug therapy
- patients with uncontrolled infection
- known DPD deficiency
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118377
Locations
| United States, California | |
| San Francisco, California, United States, 94143-0780 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60614 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pittsburgh, Pennsylvania, United States, 15261 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38105 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Hoffmann-La Roche
Pediatric Brain Tumor Consortium
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01118377 History of Changes |
| Other Study ID Numbers: | NO21125, PBTC-030 |
| Study First Received: | April 15, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Capecitabine Fluorouracil |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013