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Melanoma: HELP
Articles by William J. Maples
Based on 4 articles published since 2010
(Why 4 articles?)

Between 2010 and 2020, William J. Maples wrote the following 4 articles about Melanoma.
+ Citations + Abstracts
1 Clinical Trial Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance). 2018

Vera Aguilera, Jesus / Rao, Ravi D / Allred, Jacob B / Suman, Vera J / Windschitl, Harold E / Kaur, Judith S / Maples, William J / Lowe, Val J / Creagan, Edward T / Erickson, Lori A / Markovic, Svetomir. ·Mayo Clinic and Mayo Foundation, Rochester, Minnesota vera.jesus@mayo.edu. · St. Agnes Cancer Center, Fresno, California. · Mayo Clinic and Mayo Foundation, Rochester, Minnesota. · Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota. · Mayo Clinic Jacksonville, Jacksonville, Florida. ·Oncologist · Pubmed #29666297.

ABSTRACT: LESSONS LEARNED: Everolimus does not have sufficient activity to justify its use as single agent in metastatic melanoma.Patients treated with 10 mg per day dose were most likely to require dose reductions.Everolimus appeared to reduce the numbers of regulatory T cells in approximately half of the treated patients; unfortunately, these effects were not correlated with clinical outcomes. BACKGROUND: Everolimus (RAD-001) is an orally active rapamycin analogue shown in preclinical data to produce cytostatic cell inhibition, which may be potentially beneficial in treating melanoma. We conducted a phase II study to evaluate the efficacy and safety of everolimus in patients with unresectable metastatic melanoma (MM). METHODS: This study included two cohorts; cohort 1 received 30 mg of everolimus by mouth (PO) weekly, and cohort 2 was dosed with 10 mg of everolimus PO daily. The endpoints of the study were safety, 16-week progression-free survival (PFS), overall survival (OS), and measures of immunomodulatory/antiangiogenic properties with therapy. Tumor samples before therapy and at week 8 of treatment were analyzed. Peripheral blood plasma or mononuclear cell isolates collected prior to therapy and at weeks 8 and 16 and at time of tumor progression were analyzed for vascular endothelial growth factor and regulatory T-cell (Treg) measurements. RESULTS: A total of 53 patients were enrolled in cohort 1 ( CONCLUSION: Everolimus does not have sufficient single-agent activity in MM; however, we have identified evidence of biological activity to provide a potential rationale for future combination studies.

2 Clinical Trial Phase II study of temozolomide (TMZ) and everolimus (RAD001) therapy for metastatic melanoma: a North Central Cancer Treatment Group study, N0675. 2014

Dronca, Roxana S / Allred, Jacob B / Perez, Domingo G / Nevala, Wendy K / Lieser, Elizabeth A T / Thompson, Michael / Maples, William J / Creagan, Edward T / Pockaj, Barbara A / Kaur, Judith S / Moore, Timothy D / Marchello, Benjamin T / Markovic, Svetomir N. ·*Mayo Clinic Rochester, Rochester †Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, MN ‡Mayo Clinic Arizona, Scottsdale, AZ §Columbus CCOP, Columbus, OH ∥Montana Cancer Consortium, Billings, MT. ·Am J Clin Oncol · Pubmed #23357973.

ABSTRACT: OBJECTIVE: Mammalian 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. METHODS: We 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. RESULTS: Of 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). CONCLUSIONS: The 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.

3 Clinical Trial Phase II trial of intravenous administration of Reolysin(®) (Reovirus Serotype-3-dearing Strain) in patients with metastatic melanoma. 2012

Galanis, Evanthia / Markovic, Svetomir N / Suman, Vera J / Nuovo, Gerard J / Vile, Richard G / Kottke, Timothy J / Nevala, Wendy K / Thompson, Michael A / Lewis, Jean E / Rumilla, Kandelaria M / Roulstone, Victoria / Harrington, Kevin / Linette, Gerald P / Maples, William J / Coffey, Matt / Zwiebel, James / Kendra, Kari. ·Mayo Clinic, Rochester, Minnesota 55905, USA. galanis.evanthia@mayo.edu ·Mol Ther · Pubmed #22871663.

ABSTRACT: Reovirus, a replication competent RNA virus, has preclinical activity against melanoma lines and xenografts. We conducted a phase II trial of reovirus in metastatic melanoma patients. Patients received 3 × 10(10) TCID50 on days 1-5 of each 28 day cycle, administered intravenously. Twenty-one eligible patients were enrolled. Treatment was well tolerated without any dose reductions having to be implemented. Post-treatment biopsy samples were obtained in 15 patients, 13/15 contained adequate tumor for correlative analysis. In two patients, productive reoviral replication (viral antigen coexpression with tubulin) was demonstrated, despite increase in neutralizing antibody titers. There were no objective responses although 75-90% tumor necrosis, consistent with treatment effect, was observed in one patient who had metastatic lesions surgically removed. Median time to progression and survival were 45 days (range 13-96 days) and 165 days (range 15 days-15.8 months) respectively. In conclusion, reovirus treatment was well tolerated in metastatic melanoma patients; viral replication was demonstrated in biopsy samples. Based on preclinical data showing synergy with taxane and platinum compounds, a phase II combination trial in metastatic melanoma patients is ongoing.

4 Clinical Trial A study of paclitaxel, carboplatin, and bortezomib in the treatment of metastatic malignant melanoma: a phase 2 consortium study. 2010

Croghan, Gary A / Suman, Vera J / Maples, William J / Albertini, Mark / Linette, Gerald / Flaherty, Lawrence / Eckardt, John / Ma, Cynthia / Markovic, Svetomir N / Erlichman, Charles. ·Department of Medical Oncology, Melanoma Study Group, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. croghan.gary@mayo.edu ·Cancer · Pubmed #20564112.

ABSTRACT: BACKGROUND: Chemotherapy has not been reported to have a significant impact on survival for patients with metastatic melanoma. Bortezomib was shown to have additive/synergistic effects with several chemotherapeutic agents, including paclitaxel and platinum. A phase 1 trial of this 3-drug combination reported that 6 of 28 patients treated with bortezomib followed by paclitaxel and carboplatin achieved a partial response (including 2 of 5 patients with metastatic melanoma). METHODS: A 2-stage phase 2 clinical trial was conducted to assess the antitumor activity of this 3-agent combination in patients with metastatic melanoma who had received at most 1 prior chemotherapy for metastatic disease. Treatment included bortezomib at a dose of 1.3 mg/m2 intravenously on Days 1, 4, and 8; paclitaxel at a dose of 175 mg/m2; and carboplatin at an area under the concentration (AUC) of 6 on Day 2 of a 21-day cycle. The primary endpoint of this trial was tumor response rate (TRR). RESULTS: Seventeen eligible patients were enrolled. A median of 4 cycles were administered (range, 1-7 cycles). Three patients discontinued treatment due to persistent grade 4 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]) neutropenia with grade 3 leukopenia (2 patients) or grade 4 pulmonary embolism (1 patient). Grade>or=3 toxicities included neutropenia (71%), leukopenia (41%), thrombocytopenia (29%), and arthralgia (12%). Two partial responses were observed (TRR, 11.8%). Four patients had stable disease at >12 weeks. The median progression-free survival was 3.2 months, and the median overall survival was 7.0 months. CONCLUSIONS: Due to insufficient clinical efficacy, this trial did not proceed to second-stage accrual. The combination of paclitaxel, carboplatin, and bortezomib demonstrated limited clinical benefit and was associated with significant toxicity.