- |||||||||| Avastin (bevacizumab) / Roche, 9-ING-41 / Actuate Therap
[VIRTUAL] Malignant glioma subset from Actuate 1801: A phase 1/2 study of 9-ING-41, a glycogen synthase kinase 3 beta (GSK-3β) inhibitor, as a single agent and combined with chemotherapy, in patients with refractory hematologic malignancies or solid tumors. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1980;
P1/2
In chemoresistant PDX models of glioblastoma (GBM), 9-ING-41 enhanced the antitumor effect of CCNU and CPT-11...All received first-line radiation and temozolomide (18/18), prior therapies for recurrences included nitrosoureas (15/18), bevacizumab (8/18), TTFields (6/18), immune checkpoint inhibitor (4/18)...Best overall response: 1 minimal response (-43%) after 2 cycles of 9-ING-41 and lomustine . These results show 9-ING-41 alone or in combination is safe and warrants further study in glioma patients.
- |||||||||| temozolomide / Generic mfg.
[VIRTUAL] Digital measurement of functional status of patients with glioblastoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1942;
P1/2
Selinexor (SEL) is a first-in class, oral, selective inhibitor of nuclear export which blocks exportin 1 (XPO1), forcing the nuclear retention and reactivation of tumor suppressor proteins, ultimately causing cell death in cancer cells...XPORT-GBM-029 (NCT04421378) is a phase 1 dose finding study followed by an open-label randomized phase 2, 3-arm trial to evaluate SEL in combination with standard therapies for newly diagnosed and recurrent GBM: Arm A (ndGBM, uMGMT) – radiation +/- SEL; Arm B (ndGBM, mMGMT) – radiation and temozolomide +/- SEL; Arm C (rGBM) – lomustine +/- SEL at first relapse... XPORT-GBM-029 trial is probably the first large, prospective, longitudinal study in GBM patients employing digital markers and may provide useful information regarding the utility of wearable and mobile devices for measuring functional outcomes in clinical trials.
- |||||||||| lithium carbonate ER / Generic mfg., irinotecan / Generic mfg.
Journal: The use of a Gene Expression Signature and Connectivity Map to repurpose drugs for Bipolar Disorder. (Pubmed Central) - Apr 28, 2021
XPORT-GBM-029 trial is probably the first large, prospective, longitudinal study in GBM patients employing digital markers and may provide useful information regarding the utility of wearable and mobile devices for measuring functional outcomes in clinical trials. This study shows that GES and CMap can be used as tools to repurpose drugs for BD.
- |||||||||| Stivarga (regorafenib) / Bayer
Clinical, Journal: A Molecular Signature associated with prolonged survival in Glioblastoma patients treated with Regorafenib. (Pubmed Central) - Apr 28, 2021
The study provides evidence that a signature based on the expression of five biomarkers could help identifying a subgroup of GBM patients exhibiting a striking survival advantage when treated with regorafenib. Despite the presented results must be confirmed in larger replication cohorts, the study highlights potential biomarker options to help guiding the clinical decision among regorafenib and other treatments in patients with relapsing GBM.
- |||||||||| Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial primary completion date: A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer (clinicaltrials.gov) - Apr 22, 2021
P1, N=90, Recruiting,
Despite the presented results must be confirmed in larger replication cohorts, the study highlights potential biomarker options to help guiding the clinical decision among regorafenib and other treatments in patients with relapsing GBM. Trial primary completion date: Mar 2021 --> Mar 2022
- |||||||||| lomustine / Generic mfg., prednisolone / Generic mfg.
Journal: Lymphoid leukemia in five bearded dragons (Pogona vitticeps). (Pubmed Central) - Apr 20, 2021
Trial primary completion date: Mar 2021 --> Mar 2022 The present report represented the first description of lomustine as a primary chemotherapeutic agent for the treatment of lymphocytic leukemia in bearded dragons and provided information on response to treatment, adverse effects, and survival times.
- |||||||||| Avastin (bevacizumab) / Roche
Retrospective data, Review: Optimal Therapies for Recurrent Glioblastoma: A Bayesian Network Meta-Analysis. (Pubmed Central) - Apr 16, 2021
Ranking and cluster analysis indicated that bevacizumab (BEV) plus CCNU and regorafenib had a higher efficacy on the ORR, 6-m PFS rate and OS, and that BEV monotherapy or BEV combined with active drug therapies was advantageous for the ORR and 6-m PFS rate...BEV monotherapy alone or combined with active drug therapies are recommended in patients with severe neurological symptoms. Advanced therapy, such as TTF and immunotherapy, remain to be investigated in future studies.
- |||||||||| lomustine / Generic mfg., prednisolone / Generic mfg.
Journal: Unusual splenic B-cell lymphoma in two related Sumatran tigers (Panthera tigris sumatrae). (Pubmed Central) - Apr 7, 2021
Both tigers achieved positive clinical responses and long-term survival by means of different treatment modalities. The finding of such an unusual neoplasm in a male tiger and its male offspring was noteworthy, raising the possibility of a genetic predisposition for this lymphoma type.
- |||||||||| Avastin (bevacizumab) / Roche
FDA event, Review, Journal: Current FDA-Approved Therapies for High-Grade Malignant Gliomas. (Pubmed Central) - Apr 7, 2021
The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months...Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields)...TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.
- |||||||||| disulfiram / Generic mfg.
Trial completion: Disulfiram in Recurrent Glioblastoma (clinicaltrials.gov) - Mar 18, 2021
P2/3, N=88, Completed,
Verbal working memory deteriorated, while other neurocognitive domains did not seem to be impacted negatively by the treatment. Active, not recruiting --> Completed
- |||||||||| RG2833 / BioMarin
[VIRTUAL] Brain penetrant HDAC inhibitor RG2833 induces DIPG cell death and synergizes with lomustine (Channel 06) - Mar 11, 2021 - Abstract #AACR2021AACR_1942;
The pan-histone deacetylase (HDAC) inhibitor panobinostat showed great activity against DIPG in pre-clinical models, but has poor blood brain barrier penetration and demonstrated significant toxicity in clinical trials...RG2833 demonstrated cytotoxicity against temozolomide-resistant glioblastoma and downregulated the NFĸB pathway...We will next assess combination treatment in vitro and in vivo for apoptotic effects. This data indicates that selective HDAC inhibitor RG2833 may be a promising therapeutic candidate for DIPG.
- |||||||||| Fyarro (nanoparticle albumin-bound rapamycin) / Aadi Biosci
Trial completion date, Trial primary completion date: Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Mar 10, 2021
P2, N=56, Recruiting,
This data indicates that selective HDAC inhibitor RG2833 may be a promising therapeutic candidate for DIPG. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| lomustine / Generic mfg., temozolomide / Generic mfg., carmustine / Generic mfg.
Preclinical, Journal: Design, synthesis, DNA binding studies and evaluation of anticancer potential of novel substituted biscarbazole derivatives against human glioma U87 MG cell line. (Pubmed Central) - Mar 9, 2021
The compound 34 showed the most significant in vitro cytotoxicity (IC = 3.9 µM) against human glioma U87 MG cell line and was found to be better than standard drugs used for the treatment of brain tumors such as temozolomide (IC = 100 µM) and carmustine (IC = 18.2 µM) respectively...Our results demonstrated groove binding mode of interaction of the compound 34 with CT-DNA with a plausible static bio-molecular quenching rate constant (Kq) 1.7 × 10 M s. The studies of biscarbazole derivatives are anticipated to develop potential novel anticancer agents against brain tumors.
- |||||||||| lomustine / Generic mfg., vincristine / Generic mfg.
Clinical, Review, Journal, Residual disease: Neuro-Oncology Practice Clinical Debate: Early treatment or observation for patients with newly diagnosed oligodendroglioma and small-volume residual disease. (Pubmed Central) - Mar 6, 2021
Patients and physicians both desire maximally effective therapy with minimal toxicity, and it remains unclear whether some patients with macroscopic residual disease after surgery can safely delay therapy, to avoid or delay toxicity, while simultaneously preserving the full benefits of treatment. In this article, experts in the field discuss the rationale for the approaches of up-front treatment with chemoradiotherapy and initial observation, respectively.
- |||||||||| lomustine / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma (clinicaltrials.gov) - Feb 21, 2021
P2, N=7, Completed,
Importantly, this post hoc analysis supports the notion that patients with IDH-mutant high-risk LGG regardless of codeletion status receive benefit from the addition of PCV. Recruiting --> Completed | N=34 --> 7 | Trial completion date: Nov 2021 --> Feb 2021 | Trial primary completion date: Nov 2021 --> Feb 2021
- |||||||||| Fyarro (nanoparticle albumin-bound rapamycin) / Aadi Biosci
Trial completion date, Trial primary completion date: Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma (clinicaltrials.gov) - Feb 18, 2021
P2, N=56, Recruiting,
Trial completion date: Nov 2020 --> Jun 2021 Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
- |||||||||| Avastin (bevacizumab) / Roche
Trial completion, Enrollment change, Trial completion date: EORTC 26101: Bevacizumab and Lomustine for Recurrent GBM (clinicaltrials.gov) - Feb 15, 2021
P3, N=592, Completed,
Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021 Active, not recruiting --> Completed | N=433 --> 592 | Trial completion date: Aug 2018 --> Apr 2020
- |||||||||| Avastin (bevacizumab) / Roche
Retrospective data, Review: Effectiveness of Lomustine Combined With Bevacizumab in Glioblastoma: A Meta-Analysis. (Pubmed Central) - Feb 9, 2021
This study shows that lomustine and bevacizumab can effectively increase OS, PFS, and 6-month PFS in patients with GBM. The encouraging results of the lomustine and bevacizumab combination therapy for GBM should be studied in more clinical trials in the future.
- |||||||||| lomustine / Generic mfg., temozolomide / Generic mfg., vincristine / Generic mfg.
Clinical, Journal: A case series of pediatric survivors of anaplastic pleomorphic xanthoastrocytoma. (Pubmed Central) - Feb 7, 2021
The third patient recurred and went on to receive a second GTR and 6 cycles of lomustine, vincristine, and procarbazine...This case series supports the use of adjuvant chemoradiotherapy in the treatment of APXA. The genetic landscape may be informative for optimizing treatment and prognosis.
- |||||||||| lomustine / Generic mfg., busulfan / Generic mfg.
Clinical, Journal: Risk Factors for Small Adult Height in Childhood Cancer Survivors. (Pubmed Central) - Feb 2, 2021
CCS are at a high risk of SAH. CCS treated with radiotherapy, busulfan, or lomustine should be closely monitored for growth, puberty onset, and potential pituitary deficiency.
- |||||||||| eflornithine / Orbus Therap
Trial completion date, Trial primary completion date: STELLAR: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (clinicaltrials.gov) - Jan 27, 2021
P3, N=340, Recruiting,
The patients who achieved CR 3 months after the transplantation had higher rates of PFS (P=0.007) and OS (P=0.003).ConclusionIEAC and CEAC regimens prior to by ASCT are both safe and effective in the treatment of lymphoma and can be used as alternative conditioning regimens for lymphoma patients undergoing ASCT. Trial completion date: Jun 2020 --> Dec 2021 | Trial primary completion date: Jun 2020 --> Dec 2021
- |||||||||| lomustine / Generic mfg.
Clinical, Journal: Nimustine Treatment of 11 Cases of Canine Histiocytic Sarcoma. (Pubmed Central) - Jan 23, 2021
ACNU was well tolerated and showed a similar outcome to that seen for lomustine, which is a drug commonly used to treat canine HS, in terms of overall survival and PFS in the current study population. Further investigations will need to be undertaken to definitively determine if ACNU is an appropriate alternative to lomustine for the treatment of HS.
- |||||||||| temozolomide / Generic mfg.
Review, Journal: Radiation and chemotherapy for high-risk lower grade gliomas: Choosing between temozolomide and PCV. (Pubmed Central) - Jan 21, 2021
At present, we conclude that current evidence does not support the widespread use of TMZ over PCV for all patients with high-risk LGG, and we instead recommend tailoring chemotherapy recommendation based on IDH status, favoring adjuvant PCV for patients with any IDH mutant tumors, both those that harbor 1p/19q codeletion and those non-1p/19q codeleted. Given the critical role radiation plays in the treatment of LGG, radiation oncologists should be actively involved in discussions regarding chemotherapy choice in order to optimize treatment for their patients.
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Real world outcomes for treatment of diffuse large B cell Lymphoma in patients aged 80 and over () - Jan 5, 2021 - Abstract #BSHI2020BSH-I_340;
The median OS of 33 months for patients treated with curative intent is similar to 29 months reported previously by the GELA group for R‐miniCHOP in patients aged over 80. However only 50% of this age group were felt to be fit enough to receive this treatment in our cohort and the survival for those treated palliatively was short indicating an unmet need for effective well‐tolerated treatment in this group.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] Experiences of providing commercial Chimeric Antigen Receptor (CAR‐T) cell therapy at the Northern Centre for Cancer Care () - Jan 5, 2021 - Abstract #BSHI2020BSH-I_19;
Six (40%) received steroids (in all cases this was IV dexamethasone) for issues related directly to CAR‐T therapy...Four patients (29% of cohort available to follow‐up) have died after CAR‐T infusion. Progression‐free survival rates as calculated at standardised follow‐up points were 71% at 28 days, 31% at 3 months, and 27% at 6 months after CAR‐T infusion. One patient who had initial disease progression later had a subsequent complete response after receiving another line of treatment.
- |||||||||| lomustine / Generic mfg.
Journal: Design and Development of Lomustine Loaded Chitosan Nanoparticles for Efficient Brain Targeting. (Pubmed Central) - Jan 2, 2021
One patient who had initial disease progression later had a subsequent complete response after receiving another line of treatment. In conclusion, the results suggested that the optimised lomustine loaded chitosan nanoparticles are useful for brain targeting hence hold the potential for further research and clinical application.
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