scholarly journals ACTR-88. A PHASE II STUDY OF THE EFFICACY OF HYPOFRACTIONATED RADIATION THERAPY WITH BEVACIZUMAB AND TEMOZOLOMIDE FOLLOWED BY MAINTENANCE TEMOZOLOMIDE AND BEVACIZUMAB FOR RECURRENT HIGH-GRADE GLIOMAS

2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi19-vi20
Author(s):  
Karan Dixit ◽  
Priya Kumthekar ◽  
Timothy Kruser ◽  
Sean Sachdev ◽  
John A Kalapurakal ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
High Grade ◽  
High Grade Gliomas ◽  
Hypofractionated Radiation Therapy ◽  
Hypofractionated Radiation

Single-Arm Phase II Study of Conformal Radiation Therapy and Temozolomide plus Fractionated Stereotactic Conformal Boost in High-Grade Gliomas

2010 ◽  
Vol 186 (10) ◽  
pp. 558-564 ◽  
Author(s):  
Mario Balducci ◽  
Giuseppina Apicella ◽  
Stefania Manfrida ◽  
Annunziato Mangiola ◽  
Alba Fiorentino ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
High Grade ◽  
Conformal Radiation Therapy ◽  
High Grade Gliomas

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.

scholarly journals Are three weeks hypofractionated radiation therapy (HFRT) comparable to six weeks for newly diagnosed glioblastoma patients? Results of a phase II study

Oncotarget ◽  
2017 ◽  
Vol 8 (40) ◽  
pp. 67696-67708 ◽  
Author(s):  
Pierina Navarria ◽  
Federico Pessina ◽  
Stefano Tomatis ◽  
Riccardo Soffietti ◽  
Marco Grimaldi ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Newly Diagnosed ◽  
Newly Diagnosed Glioblastoma ◽  
Hypofractionated Radiation Therapy ◽  
Hypofractionated Radiation

Temozolomide as First-Line Agent in Treating High-Grade Gliomas: Phase II Study

2004 ◽  
Vol 67 (1/2) ◽  
pp. 77-81 ◽  
Author(s):  
S. Chibbaro ◽  
L. Benvenuti ◽  
A. Caprio ◽  
S. Carnesecchi ◽  
F. Pulerà ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
High Grade ◽  
First Line ◽  
High Grade Gliomas

Procarbazine and High-Dose Tamoxifen as a Second-Line Regimen in Recurrent High-Grade Gliomas: A Phase II Study

1999 ◽  
Vol 17 (2) ◽  
pp. 645-645 ◽  
Author(s):  
Alba A. Brandes ◽  
Mario Ermani ◽  
Sergio Turazzi ◽  
Elvira Scelzi ◽  
Franco Berti ◽  
...  
Keyword(s):  
Phase Ii ◽  
Response Rate ◽  
Chemotherapy Regimen ◽  
Phase Ii Study ◽  
Tumor Control ◽  
High Dose ◽  
High Grade ◽  
Second Line ◽  
First Line ◽  
High Grade Gliomas

PURPOSE: A phase II study was conducted in patients with high-grade gliomas that recurred after surgery plus radiotherapy and a first-line nitrosourea-based regimen. Our aim was to investigate the efficacy of procarbazine (PCB) combined with high-dose tamoxifen in relation to tumor control, toxicity, and time to progression (TTP). PATIENTS AND METHODS: Fifty-three patients were treated with procarbazine in repeated 30-day courses at 100 mg/m2/d plus tamoxifen 100 mg/d, with a 30-day interval between courses. Thirty-four patients had been pretreated with a first-line nitrosourea-based chemotherapy regimen (group A), and 19 patients had also been pretreated with a second-line chemotherapy regimen consisting of carboplatin and teniposide (group B). Twenty-one of the patients had also been procarbazine pretreated, whereas the remaining 32 patients were not procarbazine pretreated. RESULTS: The response was assessed in 51 patients, 28 of whom had glioblastoma multiforme (GBM) and 23 of whom had anaplastic astrocytoma (AA). There were two complete responses (CR) (4%) and 13 partial responses (PR) (25.5%). The overall response rate (CR + PR) was 29.5% (SE, 6.4; 95% confidence interval [CI], 23 to 35.8). Seventeen patients (32%) had stable disease (SE, 6.2; 95% CI, 21 to 33.6). The median TTP was 13 weeks for patients with GBM and 33 weeks for patients with AA (P = .006). The median survival time (MST) was 27 weeks for patients with GBM and 57 weeks for those with AA (P = .006). CONCLUSION: Combined PCB and tamoxifen as a second-line regimen gave a reasonably high response rate in patients with heavily pretreated high-grade gliomas. However, although it resulted in an improvement in the patients' quality of life and/or performance status, it was not followed by an increased TTP or MST.

Intravenous administration of high doses of carboplatin in multimodal treatment of high grade gliomas: a phase II study

1996 ◽  
Vol 138 (2) ◽  
pp. 215-220 ◽  
Author(s):  
P. Lunardi ◽  
J. Osman Farah ◽  
L. Mastronardi ◽  
F. Puzzilli ◽  
F. M. Lo Bianco
Keyword(s):  
Phase Ii ◽  
Intravenous Administration ◽  
Multimodal Treatment ◽  
Phase Ii Study ◽  
High Grade ◽  
High Grade Gliomas ◽  
High Doses

BMX-HGG: Phase II trial of newly diagnosed high-grade glioma treated with concurrent radiation therapy, temozolomide, and BMX-001.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS2577-TPS2577
Author(s):  
Katherine B. Peters ◽  
Adam Louis Cohen ◽  
Nicholas A. Butowski ◽  
John L. Villano ◽  
Pierre Giglio ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
White Matter ◽  
Cancer Therapy ◽  
Phase Ii ◽  
Functional Assessment ◽  
Phase Ii Study ◽  
High Grade Glioma ◽  
High Grade ◽  
Newly Diagnosed ◽  
Who Grade

TPS2577 Background: Patients diagnosed with malignant high-grade gliomas (WHO grade III-IV) experience significant morbidity and mortality associated with these cancers. While the mainstay of therapy for patients with newly diagnosed high-grade glioma is surgery followed by concurrent chemotherapy and radiation therapy (RT), the outcomes remain very poor. BMX-001 (MnTnBuOE-2-PyP5+) is a metalloporphyrin with differential action in response to radiation therapy and chemotherapy-induced oxidative stress. Early preclinical studies demonstrated BMX-001’s ability to act as a radioprotectant to healthy tissue such as a central nervous white matter and as a radiosensitizer to cancer cells, in particular, human glioblastoma xenografts. We evaluated the safety of BMX-001 in combination with concurrent RT and temozolomide (TMZ) in a phase I study of newly diagnosed high-grade glioma patients, and we found that BMX-001 is safe and well-tolerated in this population. The maximum tolerated dose of BMX-001 during concurrent RT and TMZ was determined to be 28 mg delivered subcutaneously (SC) followed by 16 biweekly SC doses at 14 mg (Peters et al., Neuro-Oncology 2018). Methods: For this multi-site, open-label, phase II study (NCT02655601), we will randomize approximately 160 patients 1:1 to concurrent RT and TMZ with BMX-001 versus concurrent RT and TMZ alone. Key eligibility criteria include newly diagnosed histologically confirmed high-grade glioma (WHO III-IV), 18 ≥ years, and Karnofsky performance status ≥ 70%. The primary endpoint is overall survival. Secondary endpoints include cognitive performance as assessed by standardized cognitive testing, bone marrow protection, safety and tolerability, progression-free survival, overall tumor response rate, and plasma pharmacokinetics. Exploratory endpoints are health-related quality of life (as assessed by Functional Assessment of Cancer Therapy–Brain, Functional Assessment of Cancer Therapy-Cognition, and Functional Assessment of Chronic Illness Therapy-Fatigue), qualitative hair loss, and white matter integrity (as measured by MRI diffusion tensor/susceptibility imaging). Since November 2018, this phase II study has enrolled 64 of 160 high-grade glioma patients at six sites with future sites planned to be implemented. Clinical trial information: NCT02655601 .

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