Doctors Try Genetically Modified Poliovirus As Experimental Brain Cancer Treatment

Excerpt:

“A genetically modified poliovirus may help some patients fight a deadly form of brain cancer, researchers report.

“The experimental treatment seems to have extended survival in a small group of patients with glioblastoma who faced a grim prognosis because standard treatments had failed, Duke University researchers say.

” ‘I’ve been doing this for 50 years and I’ve never seen results like this,’ says Dr. Darell Bigner, the director emeritus of the The Preston Robert Tisch Brain Tumor Center at the Duke Cancer Institute, who is helping develop the treatment.”

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New Approach to Treating Glioblastoma Could Add Years to Patients’ Lives

Excerpt:

A new way of treating glioblastoma — the deadly brain tumor currently ailing Arizona Sen. John McCain — with a personalized vaccine is giving some patients in a clinical trial more time.

“The vaccination, called DCVax-L, is made out of a patient’s own cells and uses them to jumpstart the immune system and attack the tumor. In the trial, some patients survived for more than 36 months — more than a year and a half longer than current life expectancy after glioblastoma diagnosis.”

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MimiVax Announces Positive Interim Results from Phase II Trial of SurVaxM Immunotherapy for the Treatment of Newly Diagnosed Glioblastoma

Excerpt:

“MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, today announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM). These promising interim results support further development of SurVaxM in combination with standard therapy as a potential treatment for glioblastoma. A randomized trial of SurVaxM in glioblastoma is planned, pending completion of this study and review at the end of Q4 2018.”

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Study Evaluating VBI-1901 Enrolling Recurrent GBM Patients in Second Dose Group

Excerpt:

“An Independent Data and Safety Monitoring Board (DSMB) unanimously recommended that the Phase 1/2 clinical trial evaluating VBI Vaccines’ VBI-1901 continue to enroll patients with recurrent glioblastoma (GBM) in a second study arm.

“The positive review recommended the study continue without modification, after scanning through all safety data from the first group of patients, who received the lowest VBI-1901 dose. Enrollment now has commenced for the second, intermediate-dose study arm.”

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Carboxyamidotriazole Orotate Shows Promising Activity in Brain Cancers

Excerpt:

“Carboxyamidotriazole orotate (CTO) in combination with temozolomide (Temodar), with or without radiotherapy, produced positive safety and efficacy results in a phase Ib study of patients with glioblastoma (GBM) or anaplastic gliomas.

“Forty-two patients were divided into 2 cohorts and received treatment. Cohort 1 included 27 patients with recurrent, temozolomide-refractory anaplastic gliomas or GBM. Twenty-one patients were assigned to a regimen of 219 to 812.5 mg/m2 of once-daily CTO in escalating doses and 6 were assigned to a fixed daily dose of 600 mg of CTO. All 27 patients received 150 mg/m2 of temozolomide on days 1 to 5 of each 28-day cycle.”

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NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma

Excerpt:

“NovoCure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.

“NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.”

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Tumor-Treating Fields for Glioblastoma Do Not Negatively Impact Quality of Life

Excerpt:

“The addition of tumor-treated fields to standard therapy with temozolomide prolonged deterioration-free survival without negatively influencing health-related quality of life among patients with glioblastoma, according to a secondary analysis of a phase 3 clinical trial published in JAMA Oncology.

“However, tumor-treating fields, or TTFields (Optune, Novocure) — alternating electrical fields delivered via four transducer arrays at an intermediate frequency of 200 MHz (1-3 V/cm) placed on the shaved scalp of patients and connected to a portable medical device — also caused skin irritation in more than half of patients.”

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Bevacizumab/Lomustine Combinations Falls Short in Phase III Glioblastoma Trial

Excerpt:

“Treatment with lomustine (Gleostine) plus bevacizumab (Avastin) provided a slightly improved progression-free survival (PFS), but did not demonstrate an overall survival (OS) advantage over treatment with lomustine alone in patients with progressive glioblastoma, according to results of a randomized phase III trial published in theNew England Journal of Medicine.

“There were a total of 329 OS events (75.3%) in patients who received the combination, which did not meet the endpoint for a statistically significant benefit. The median OS was 9.1 months (95% CI, 8.1-10.1) in the group of patients who received the combination of lomustine and bevacizumab and 8.6 months (95% CI, 7.6-10.4) in the monotherapy group (HR, 0.95; 95% CI, 0.74-1.21). Locally assessed PFS was 4.2 months in the combination group versus 1.5 months in the monotherapy group (HR, 0.49; 95% CI, 0.39-0.61).”

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Diffusion Pharmaceuticals Begins Phase 3 Clinical Trial with TSC in Glioblastoma Multiforme

Excerpt:

“Diffusion Pharmaceuticals Inc. DFFN, +2.38% (“Diffusion” or “the Company”), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, today announced that a Phase 3 clinical trial using its lead small molecule trans sodium crocetinate (“TSC”) in patients with newly-diagnosed inoperable glioblastoma multiforme (“GBM”) brain cancer, is now open for enrollment. The trial, which has been named INTACT (INvestigating Tsc Against Cancerous Tumors), follows a previous Phase 2 GBM study in which the inoperable patient subgroup showed a nearly four-fold increase in survival compared with historical controls when TSC was added to their treatment regimen (40% alive at two years vs. 10.4%). TSC’s innovative mechanism of action affects the tumor micro-environment, making treatment-resistant cancer cells more susceptible to the tumor-killing power of conventional radiation therapy (“RT”) and chemotherapy (temozolomide) by re-oxygenation of the hypoxic portion of the tumor. The Company believes that a largely intact GBM tumor vasculature with limited surgical resection is conducive to TSC’s tumor re-oxygenation properties, and that this contributed to the survival increase in the Phase 2 GBM inoperable patient subgroup.”

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