| Label |
NCT00998010
|
| Slug |
nct00998010
|
| Trialid |
NCT00998010
|
| Lookup name |
NCT00998010
|
| Provenance |
http://clinicaltrials.gov/show/NCT00998010?displayxml=true
|
| Lastchanged date |
June 17, 2011
|
| Firstreceived results date |
|
| Firstreceived date |
October 17, 2009
|
| Id info nct id |
NCT00998010
|
| Overall status |
Recruiting
|
| Id info secondary id |
P30CA016042
|
| Biospec retention |
|
| Required header link text |
Link to the current ClinicalTrials.gov record.
|
| Enrollment |
70
|
| Number of arms |
1
|
| Is section 801 |
Yes
|
| Is fda regulated |
Yes
|
| Brief title |
Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
|
| Acronym |
|
| Official title |
Phase II Trial of Velcade (Bortezomib) in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme
|
| Study type |
Interventional
|
| Id info nct alias |
|
| Completion date |
|
| Verification date |
June 2011
|
| Why stopped |
|
| Id info org study id |
CDR0000657015
|
| Required header url |
http://clinicaltrials.gov/show/NCT00998010
|
| Study design |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
| Source |
University of California, Los Angeles
|
| Primary completion date |
October 2013
|
| Brief summary |
|
| Number of groups |
|
| Required header download date |
Information obtained from ClinicalTrials.gov on February 07, 2012
|
| Phase |
Phase 2
|
| Start date |
June 2011
|
| Has expanded access |
No
|
| Biospec descr |
|
| Detailed description |
OBJECTIVES:
Primary
- Estimate the overall survival at 2 years of patients with newly diagnosed glioblastoma
multiforme treated with bortezomib in combination with temozolomide and regional
radiotherapy followed by maintenance therapy comprising bortezomib and temozolomide.
Secondary
- Investigate further the safety and tolerability of this regimen in these patients.
- Determine the molecular characterization of tumor tissue and correlate these findings
with response.
OUTLINE: This is a multicenter study.
- Adjuvant chemotherapy: Patients receive bortezomib IV on days 1, 4, 8, 11, 29, 32, 36,
and 39 and oral temozolomide on days 1-42. Patients undergo external-beam fractionated
regional radiotherapy 5 days a week for 6 weeks in the absence of disease progression
or unacceptable toxicity.
- Maintenance: Beginning 2-6 weeks after radiotherapy, patients receive bortezomib IV on
days 1, 4, 8, and 11 and oral temozolomide on days 1-5. Treatment repeats every 28 days
for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline (from surgery) and periodically during study
for further analysis.
After completion of study therapy, patients are followed up periodically.
|
| Condition browse |
584589332d73766e711f6c4843226abc
|
| Intervention browse |
cb9d0f95f1e6cd90e2a0b0d3acfeb7ff
|
| Responsible party |
f75cba5b17a7e3a06c5fda525c79837c
|
| Overall contact |
Albert Lai, M.D. (Contact)
|
| Overall contact backup |
None
|
| Sponsor group |
fd67cf4a7c4835438de4d3e26ce65896
|
| Oversight info |
United States: Food and Drug Administration (Oversight_info)
|
| Eligibility |
b6c6149ed38bedaf916066375b932319
|
| Keywords |
adult giant cell glioblastoma,
adult glioblastoma,
adult gliosarcoma
|
| Conditions |
Brain and Central Nervous System Tumors
|
| Locations |
1517d9c5c3715e686e771a715f7fbec2
|
| Links |
http://cancer.gov/clinicaltrials/UCLA-X05303
|
| Results references |
None
|
| Arm groups |
None
|
| Location countries |
United States
|
| Interventions |
external beam radiation therapy (Intervention),
adjuvant therapy (Intervention),
bortezomib (Intervention),
laboratory biomarker analysis (Intervention),
temozolomide (Intervention)
|
| Secondary outcomes |
12ac44b92dd413c84f68484d47920cf1,
26cc07031528efa3d6bd0512f1ef7780,
53353e27b42349596cda03d7659a7e7b,
f813e5ef3a857b80a4ae1a9a797d105a
|
| References |
None
|
| Primary outcomes |
bb290fcd09f73e9c3fd020336912b448
|
| Removed countries |
None
|
| Overall officials |
2e6e47f49bc4bb7655c6c6d438451b65
|
