Phase II trial of vorinostat (VOR) combined with temozolomide (TMZ) and radiation therapy (RT) for newly diagnosed glioblastoma (GBM) (Alliance N0874/ABTC-0902).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 2030-2030 ◽  
Author(s):  
Evanthia Galanis ◽  
S. Keith Anderson ◽  
C. Ryan Miller ◽  
Jann Nagina Sarkaria ◽  
Kurt A. Jaeckle ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma

Phase II trial of erlotinib with temozolomide and concurrent radiation therapy in patients with newly-diagnosed glioblastoma multiforme

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 1567-1567 ◽  
Author(s):  
C. J. Brewer ◽  
J. H. Suh ◽  
G. H. J. Stevens ◽  
G. H. Barnett ◽  
S. Toms ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Glioblastoma Multiforme ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma

scholarly journals ATIM-41. PHASE II TRIAL OF A SURVIVIN VACCINE (SurVaxM) For Newly Diagnosed Glioblastoma

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi10-vi11 ◽  
Author(s):  
Manmeet Ahluwalia ◽  
David Reardon ◽  
Ajay Abad ◽  
William Curry ◽  
Eric Wong ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma

scholarly journals Phase II study of hypofractionated radiation therapy in elderly patients with newly diagnosed glioblastoma with poor prognosis

2018 ◽  
Vol 105 (1) ◽  
pp. 47-54 ◽  
Author(s):  
Pierina Navarria ◽  
Federico Pessina ◽  
Luca Cozzi ◽  
Stefano Tomatis ◽  
Giacomo Reggiori ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Observation Time ◽  
Primary Objective ◽  
Karnofsky Performance Scale ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Hypofractionated Radiation Therapy ◽  
Hypofractionated Radiation

Objective: To evaluate hypofractionated radiation therapy (HFRT) given at therapeutic effective doses in a phase II study. Endpoints were progression-free survival (PFS) rate, overall survival (OS), and incidence of toxicity. Methods: Patients with newly diagnosed glioblastoma, age ⩾70 years, Karnofsky performance scale (KPS) score ⩽60, were enrolled. The total dose of HFRT was 52.5 Gy/15 fractions, corresponded to a biological effective dose to the tumor of 70.88 Gy. Results: Thirty patients were treated, with a median age of 75 years. Concurrent and adjuvant temozolomide chemotherapy (TMZ-CHT) was administered in 7 (23.3%) and 11 (40.7%) patients received only adjuvant TMZ-CHT. The median, 6-month PFS, and 12-month PFS were 5.0 months, 43.3%, and 20%, respectively. The median, 6-month OS, and 12-month OS were 8 months, 90%, and 30%, respectively. At the last observation time, 26 patients (86.7%) were dead and 4 (13.3%) were alive. No increase in steroid drugs was required during radiotherapy treatment and a reduction was possible in 12 (40%). Patients with KPS=60, RPA V, MGMT methylated status, neurological status stable or improved after surgery and who underwent HFRT with concurrent and adjuvant CHT, had the better outcome. Conclusion: HFRT has proven to be feasible and effective, with limited morbidity, for selected elderly and frail patients with newly diagnosed glioblastoma. The primary objective of this study was not reached in the whole cohort but only in selected patients, who need more aggressive treatment.

NABTT 0306: A randomized phase II trial of EMD 121974 in conjunction with concomitant and adjuvant temozolomide with radiation therapy in patients with newly diagnosed glioblastoma multiforme (GBM)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 2001-2001 ◽  
Author(s):  
L. B. Nabors ◽  
T. Mikkelsen ◽  
T. Batchelor ◽  
G. Lesser ◽  
M. Rosenfeld ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Survival ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Methylation Status ◽  
Newly Diagnosed ◽  
Integrin Receptor ◽  
Randomized Phase Ii ◽  
Newly Diagnosed Glioblastoma ◽  
Dose Levels

2001 Background: EMD 121974 (cilengitide) is a selective integrin receptor inhibitor that is well tolerated and has demonstrated biological activity in patients with malignant glioma. The objectives of this phase II trial were to determine safety when combined with chemoradiation and estimate the overall survival for two different doses in newly diagnosed GBM. Methods: A total of 112 patients were accrued onto the trial through the NABTT CNS consortium. Cilengitide was administered by one-hour infusion twice a week with 18 patients treated in a safety run-in phase of 6 patients at the tested dose levels of 500 mg, 1000 mg, and 2000 mg. After safety completion, 94 patients were randomly assigned to either 500 mg or 2000 mg groups. To date, 55 out of 112 (49%) patients have died. Overall survival was estimated using all patients in this trial regardless of their treating dose. Results: The median age was 55 years old (range: 22–88) and the median KPS was 90 (range: 60–100). 86 out of the 112 (76.8%) had a craniotomy as their initial surgical procedure and 25 patients (22%) had a biopsy. There were no DLTs during the safety run-in phase. The estimated median survival time is 18.9 months (95% CI: 16.3 -30.0 months) for patients treated with RT+TMZ+EMD. The trial was closed to accrual on December 31, 2007. To date, 89 out of 112 patients were alive 12 months from their initial diagnosis. The overall survival at 12 months for all patients is 79.5% (95% CI: 71–87%). MGMT methylation status and survival based on dose levels received are not currently available. Conclusions: EMD 121974 (cilengitide) is well-tolerated when combined with standard chemoradiation (TMZ+RT) and may improve survival for patients newly diagnosed with GBM given the substantial differences between the estimated median survival and that seen in the EORTC study (Stupp, N Engl J Med, 2005). [Table: see text]

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