Trial reportAmerican journal of clinical oncology2014
Phase II study of temozolomide (TMZ) and everolimus (RAD001) therapy for metastatic melanoma: a North Central Cancer Treatment Group study, N0675.
Trial report in American journal of clinical oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00521001 (A Phase II Study of Temozolomide and Everolimus), which is not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy for Metastatic Melanoma
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Mutational Characteristics of Primary Mucosal Melanoma: A Systematic Review.Molecular diagnosis & therapy · 2022Pooled it
- Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance).The oncologist · 2018Trial
- A phase II trial of everolimus, temozolomide, and radiotherapy in patients with newly diagnosed glioblastoma: NCCTG N057K.Neuro-oncology · 2015Trial
- Protocatechuic aldehyde sensitizes BRAF-mutant melanoma cells to temozolomide through inducing FANCD2 degradation.Medical oncology (Northwood, London, England) · 2025Article
- A "light" touch on PI3K to interrogate cancer drug resistance.Cell chemical biology · 2022Article
- Article
- Oncolytic herpes simplex virus and temozolomide synergistically inhibit breast cancer cell tumorigenesisOncology letters · 2021Article
- Article
- miRNA Modulation and Antitumor Activity by the Extra-Virgin Olive Oil Polyphenol Oleacein in Human Melanoma Cells.Frontiers in pharmacology · 2020Article
- Expression of Glut-1 in Malignant Melanoma and Melanocytic Nevi: an Immunohistochemical Study of 400 Cases.Pathology oncology research : POR · 2019Article
- Combination therapy with F5/35 fiber chimeric conditionally replicative adenoviruses expressing IL-24 enhances the antitumor effect of temozolomide against melanoma.Cancer medicine · 2018Article
- PI3K/AKT/mTOR pathway inhibitors inhibit the growth of melanoma cells with mTOR H2189Y mutations in vitro.Cancer biology & therapy · 2018Article
- Analysis of TSC1 mutation spectrum in mucosal melanoma.Journal of cancer research and clinical oncology · 2018Article
- Concurrent antitumor and bone-protective effects of everolimus in osteotropic breast cancer.Breast cancer research : BCR · 2017Article
- Nanosecond Pulsed Electric Fields Enhance the Anti-tumour Effects of the mTOR Inhibitor Everolimus against Melanoma.Scientific reports · 2017Article
- Therapeutic interventions to disrupt the protein synthetic machinery in melanoma.Pigment cell & melanoma research · 2015Review
- Systemic Therapy in Metastatic Melanoma.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2015Article
- Melanoma: clinical features and genomic insights.Cold Spring Harbor perspectives in medicine · 2014Review
- Adenovirus-mediated FKHRL1/TM sensitizes melanoma cells to apoptosis induced by temozolomide.Human gene therapy. Clinical development · 2014Article
- Signet-ring cell melanoma with sentinel lymph node metastasis: A case report with immunohistochemical analysis and review of the clinicopathological features.Oncology letters · 2014Article
Corrections and comments
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Authors and funding
13 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveMammalian target of rapamycin (mTOR) pathway is activated in malignant melanoma and in situ lesions as opposed to benign nevi. Inhibition of PI3K-Akt-mTOR signaling is implicated in sensitization of melanoma cells to alkylating agents (temozolomide [TMZ]) and inhibition of tumor angiogenesis.
methodsWe conducted a single-arm phase II multi-institution cooperative group study to assess the antitumor activity and safety profile of the combination of TMZ and the rapamycin derivative everolimus in patients with metastatic unresectable malignant melanoma. Patients received 10 mg/d of RAD001 for 5 of 7 days (ie, 50 mg/wk) and 200 mg/m/d of TMZ for 5 days each cycle.
resultsOf the first 39 eligible patients, 17 were PFS-9 successes, for a predetermined threshold of 18/39 patients for a positive trial. Overall, 21 of 48 patients were progression free at 9 weeks, for an event-free survival rate of 44% (95% confidence interval, 29%-59%). The median progression-free survival was 2.4 months and the median overall survival was 8.6 months. Four patients achieved a partial response; the median duration of response was 15.1 months. No complete remissions were observed. Treatment was in general well tolerated with only 1 patient discontinuing therapy due to toxicity (hyperlipidemia).
conclusionsThe combination of TMZ and RAD001 was well tolerated but failed to meet/exceed our study threshold for promising clinical activity in patients with metastatic melanoma.
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