A Study of Capecitabine (Xeloda®) and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas

NCT01118377 | Completed Phase 2 Results

• 2 other identifiers: NO21125PBTC-030
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 8

Brief Summary

This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.

Conditions

Brainstem Glioma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival was defined as the time from the initiation of treatment to the earliest date of failure (disease progression, death from any cause, or a second malignancy) or to the last assessment date for patients who did not fail. Disease progression was defined as progressive neurologic abnormalities or worsening neurologic status not explained by causes unrelated to tumor progression (eg, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, weaning of steroids, radiation necrosis, etc); or a greater than 25% increase in the bi-dimensional measurement of the tumor, as compared with the previous scan; or the appearance of a new lesion; or an increase in the doses of dexamethasone required to maintain stable neurologic status or imaging.

  Baseline to the end of the study (up to 20 weeks)

Secondary Outcomes (2)

• Overall Survival

  Baseline to the end of the study (up to 20 weeks)

• Percentage of Participants With a Tumor Response

  Baseline to the end of the study (up to 20 weeks)

Study Arms (1)

Capecitabine + radiation therapy

EXPERIMENTAL

Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.

Drug: Capecitabine; Radiation: Radiation therapy

Interventions

Capecitabine DRUG

Capecitabine was supplied as film-coated tablets.

Also known as: Xeloda

Capecitabine + radiation therapy

Radiation therapy RADIATION

Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.

Capecitabine + radiation therapy

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 2 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.

You may not qualify if:

• Patients receiving any other anticancer or experimental drug therapy.
• Patients with uncontrolled infection.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Pediatric Brain Tumor Consortium: collaborator

Study Sites (8)

Unknown Facility

San Francisco, California, 94143-0780, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20010, United States

Location

Unknown Facility

Chicago, Illinois, 60614, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15261, United States

Location

Unknown Facility

Memphis, Tennessee, 38015, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Capecitabine; Radiotherapy

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: May 6, 2010
• Study Start: May 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 6, 2014
• Results First Posted: December 3, 2013

Record last verified: 2014-02

Locations

US (8)