{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T21:16:54Z","timestamp":1772140614996,"version":"3.50.1"},"reference-count":29,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2005,2,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> IM862 is a synthetic dipeptide (l-glutamine l-tryptophan) with in vitro and in vivo antiangiogenic properties. Phase I\/II studies showed minimal toxicity and a response rate of 36% in AIDS-Kaposi's sarcoma. We report a 24-week, randomized, double-blinded, placebo-controlled phase III trial with the phase II dose, 5 mg intranasally every other day. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Two hundred two HIV-positive patients were enrolled, 104 on IM862 and 98 on placebo. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Baseline characteristics were comparable except current antiretroviral therapy: 88% versus 96% (IM862 v placebo group; P = .042). The median treatment durations were 19.5 versus 24 weeks (IM862 v placebo). No significant difference was detected in response rate (IM862, 23%; 95% CI, 15% to 32% v placebo, 21%; 95% CI, 14% to 31%; P = .46), time to response (8.5 weeks v 14 weeks; P = .024), or duration of response. However, IM862 was associated with both a shorter time to response (8.5 weeks v 14 weeks; P = .024) and shorter median time to progression (16 weeks, 95% CI, 13 to 27 weeks v 35 weeks, 95% CI, 26 to 114 weeks; P = .012). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Despite promising phase I and phase II studies, IM862 5 mg every other day was not superior to placebo and may accelerate time to progression. Highly active antiretroviral therapy alone was associated with a substantial rate of sustained tumor response and may have contributed to prior estimates of IM862 response. Therapeutic trials for AIDS-Kaposi's sarcoma must account for ongoing immune reconstitution in the setting of concurrent highly active antiretroviral therapy that may confound estimates of therapeutic activity. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2005.11.043","type":"journal-article","created":{"date-parts":[[2004,12,15]],"date-time":"2004-12-15T03:08:22Z","timestamp":1103080102000},"page":"990-998","source":"Crossref","is-referenced-by-count":41,"title":["Angiogenesis Inhibitor IM862 Is Ineffective Against AIDS-Kaposi's Sarcoma in a Phase III Trial, but Demonstrates Sustained, Potent Effect of Highly Active Antiretroviral Therapy: From the AIDS Malignancy Consortium and IM862 Study Team"],"prefix":"10.1200","volume":"23","author":[{"given":"Ariela","family":"Noy","sequence":"first","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David T.","family":"Scadden","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeannette","family":"Lee","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce J.","family":"Dezube","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Aboulafia","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anil","family":"Tulpule","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharon","family":"Walmsley","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Parkash","family":"Gill","sequence":"additional","affiliation":[{"name":"From the Memorial Sloan-Kettering Cancer Center, New York, NY; USC Keck School of Medicine, Norris Cancer Institute, Los Angeles, CA; Massachusetts General Hospital, Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, MA; AMC Operations and Statistical Center, University of Birmingham, Birmingham, AL; University of Washington; Virginia Mason Clinic, Seattle, WA; University of Toronto, Toronto Hospital, Toronto, Ontario, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"233","reference":[{"key":"BIB1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.med.54.101601.152143"},{"key":"BIB2","doi-asserted-by":"publisher","DOI":"10.1053\/sonc.2002.37263"},{"key":"BIB4","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.11253"},{"key":"BIB5","doi-asserted-by":"crossref","unstructured":"Tulpule A, Espina B, Cabriales S: IM-862 nasal solution is an active antiangiogenic agent in the treatment of AIDS-related Kaposi's sarcoma. 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