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Melanoma treatment options 1 step closer
By Dross at 2009-10-21 18:22
Melanoma treatment options 1 step closer

A targeted chemotherapyterm for the treatment of skin cancer is one step closer, after a team of University of Alberta researchers successfully synthesized a natural substance that shows exceptional potential to specifically treat this often fatal disease.

U of A chemistry professor Dennis Hall said after three years of work, his research team has successfully produced the substance called Palmerolide A.

"The potency of palmerolide is exceptional and melanoma is a very aggressive cancer for which there is almost no chemotherapeutic recourse," said Hall. "Natural substances like palmerolide offer real hope for such treatments.

"Current chemotherapy as an overall strategy is not very effective in treating melanoma. Less than a quarter of patients respond to chemotherapy and it typically only works for less than a year, and it has little to no effect on survival time. Palmerolide A as a targeted therapy may prove to be more effective [for treatment] with less toxicity," said Hall.

"One of the problems with most cancer drugs is the lack of selectivity for cancer cells versus normal cells. Preliminary data for Palmerolide A looks very promising in terms of solving this issue," he said.

"For commercialization, the structure needs to be made more 'drug-like;' smaller and more water-soluble, while preserving the potency," said Hall, who is optimistic that his U of A team is moving forward in the race to develop a treatment for melanoma.



9 comments | 1830 reads

by gdpawel on Mon, 2010-08-09 04:28
Drug significantly improves survival compared to glycoprotein 100 peptide vaccine alone, and is analogous to the way that IL-2 (Interleukin 2) works.

Jun 7, 2010

In patients with previously treated metastatic melanoma, ipilimumab -- either alone or in combination with a glycoprotein 100 (gp100) peptide vaccine -- may significantly improve overall survival, according to a study published online June 5 in the New England Journal of Medicine to coincide with a presentation at the 46th Annual Meeting of the American Society of Clinical Oncology, held from June 4 to 8 in Chicago.

F. Stephen Hodi, M.D., of the Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3 study in which 676 patients with unresectable stage III or IV melanoma that had progressed while they were being treated for metastatic disease were randomly assigned to receive either ipilimumab plus gp100, ipilimumab alone, or gp100 alone.

The researchers found that median overall survival was significantly improved in patients receiving ipilimumab plus gp100 or ipilimumab alone (10 and 10.1 months, respectively) compared to those receiving gp100 alone (6.4 months). In patients treated with ipilimumab, they found that the rate of grade 3 or 4 immune-related adverse events was 10 to 15 percent compared to a rate of 3 percent in those treated with gp100 alone, but concluded that most such events are reversible with appropriate treatment. They found that 14 deaths (2.1 percent) were related to the study drugs, including seven which were associated with immune-related adverse events.

"In some patients, side effects can be life-threatening and may be treatment-limiting," the authors conclude. "Reinduction with ipilimumab at the time of disease progression can result in further clinical benefit. Overall, our findings suggest that the T-cell potentiator ipilimumab may be useful as a treatment for patients with metastatic melanoma whose disease progressed while they were receiving one or more previous therapies."

The study was supported by Medarex and Bristol-Myers Squibb; several authors disclosed financial ties to the companies.

by gdpawel on Mon, 2010-08-09 04:32
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

F. Stephen Hodi, M.D., Steven J. O'Day, M.D., David F. McDermott, M.D., Robert W. Weber, M.D., Jeffrey A. Sosman, M.D., John B. Haanen, M.D., Rene Gonzalez, M.D., Caroline Robert, M.D., Ph.D., Dirk Schadendorf, M.D., Jessica C. Hassel, M.D., Wallace Akerley, M.D., Alfons J.M. van den Eertwegh, M.D., Ph.D., Jose Lutzky, M.D., Paul Lorigan, M.D., Julia M. Vaubel, M.D., Gerald P. Linette, M.D., Ph.D., David Hogg, M.D., Christian H. Ottensmeier, M.D., Ph.D., Celeste Lebbé, M.D., Christian Peschel, M.D., Ian Quirt, M.D., Joseph I. Clark, M.D., Jedd D. Wolchok, M.D., Ph.D., Jeffrey S. Weber, M.D., Ph.D., Jason Tian, Ph.D., Michael J. Yellin, M.D., Geoffrey M. Nichol, M.B., Ch.B., Axel Hoos, M.D., Ph.D. and Walter J. Urba, M.D., Ph.D. June 5, 2010 (10.1056/NEJMoa1003466)

Background

An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab — which blocks cytotoxic T-lymphocyte–associated antigen 4 to potentiate an antitumor T-cell response — administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma.

Methods

A total of 676 HLA-A*0201–positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival.

Results

The median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P<0.001). The median overall survival with ipilimumab alone was 10.1 months (hazard ratio for death in the comparison with gp100 alone, 0.66; P=0.003). No difference in overall survival was detected between the ipilimumab groups (hazard ratio with ipilimumab plus gp100, 1.04; P=0.76). Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events.

Conclusions

Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. Adverse events can be severe, long-lasting, or both, but most are reversible with appropriate treatment. (ClinicalTrials.gov number, NCT00094653.)

Source Information

From the Dana–Farber Cancer Institute (F.S.H.) and Beth Israel Deaconess Medical Center (D.F.M.) — both in Boston; the Angeles Clinic and Research Institute, Los Angeles (S.J.O.); St. Mary's Medical Center, San Francisco (R.W.W.); Vanderbilt University Medical Center, Nashville (J.A.S.); Netherlands Cancer Institute (J.B.H.) and VU University Medical Center (A.J.M.E.) — both in Amsterdam; University of Colorado Cancer Center, Aurora (R.G.); Institut Gustave Roussy, Villejuif, France (C.R.); University Hospital Essen, Essen (D.S., J.M.V.), German Cancer Research Center, University of Mannheim, Mannheim (J.C.H.), and Technical University Munich, Munich (C.P.) — all in Germany; Huntsman Cancer Institute, Salt Lake City (W.A.); Mount Sinai Comprehensive Cancer Center, Miami (J.L.); Christie Hospital NHS Trust, Manchester (P.L.), and Southampton University Hospitals, Southampton (C.H.O.) — both in the United Kingdom; Washington University School of Medicine, St. Louis (G.P.L.); Princess Margaret Hospital, Toronto (D.H., I.Q.); Saint Louis Hospital, Paris (C.L.); Loyola University Medical Center, Maywood, IL (J.I.C.); Memorial Sloan-Kettering Cancer Center, New York (J.D.W.); H. Lee Moffitt Cancer Center, Tampa, FL (J.S.W.); Medarex, Bloomsbury, NJ (J.T., M.J.Y., G.M.N.); Bristol-Myers Squibb, Wallingford, CT (A.H.); and the Earle A. Chiles Research Institute, Portland, OR (W.J.U.). Participating investigators are listed in the Appendix.

Address reprint requests to Dr. Hodi at the Dana–Farber Cancer Institute, 44 Binney St., Boston, MA 02115, or at [email]stephen_hodi@dfci.harvard.edu[/email].

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