PMID- 19011511 OWN - NLM STAT- MEDLINE DCOM- 20090901 LR - 20151119 IS - 1473-5636 (Electronic) IS - 0960-8931 (Linking) VI - 18 IP - 6 DP - 2008 Dec TI - A pilot study with vincristine sulfate liposome infusion in patients with metastatic melanoma. PG - 400-4 LID - 10.1097/CMR.0b013e328311aaa1 [doi] AB - Vincristine sulfate liposome infusion (VSLI) is a sphingomyelin/cholesterol liposome encapsulated formulation of vincristine that results in an extended drug circulation time and the potential for enhanced malignancy targeting, exposure, and anticancer activity. We assessed the safety and activity of VSLI in patients with metastatic melanoma. VSLI, to provide VCR 2.0 mg/m without dose capping, was infused over 1 h every 2 weeks (one cycle). Safety, tumor response, and survival were determined. Twenty-seven patients with metastatic melanoma of cutaneous (n=19), uveal (n=4), mucosal (n=1), and unknown (n=3) primary were treated. Twenty-five (93%) patients had received one or more prior lines of chemotherapy and/or immunotherapy; 14 (48%) had received a vinblastine-containing regimen. Hematologic adverse events (AEs) primarily manifested as grade 1/2 neutropenia. Nonhematologic AEs primarily consisted of gastrointestinal and constitutional symptoms of grade 1/2 severity. Grade 3 AEs included one case of paresthesia and four cases of constipation. The disease control rate in 26 evaluable patients was 31%. One complete (uveal melanoma metastatic to lung) and two partial responses (previously untreated cutaneous melanoma metastatic to the bone, brain, spleen and lung, and another with melanoma of unknown primary involving the lung, liver, and lymph node) were found. Five patients had stable disease. The median time to progression was 1.9 months. The median survival was 9.6 months with 30% of the patients alive at 1 year. VSLI was generally well tolerated and showed promising antitumor activity against metastatic melanoma and uveal melanoma in particular. A phase 2 trial to further elucidate the efficacy and safety of VSLI in metastatic uveal melanoma is ongoing. FAU - Bedikian, Agop Y AU - Bedikian AY AD - Department of Melanoma Medical Oncology, the University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. abedikia@mdanderson.org FAU - Papadopoulos, Nicholas E AU - Papadopoulos NE FAU - Kim, Kevin B AU - Kim KB FAU - Vardeleon, Anna AU - Vardeleon A FAU - Smith, Teresa AU - Smith T FAU - Lu, Biao AU - Lu B FAU - Deitcher, Steven R AU - Deitcher SR LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - Melanoma Res JT - Melanoma research JID - 9109623 RN - 0 (Antineoplastic Agents, Phytogenic) RN - 0 (Delayed-Action Preparations) RN - 0 (Liposomes) RN - 5J49Q6B70F (Vincristine) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents, Phytogenic/*administration & dosage MH - Delayed-Action Preparations MH - Female MH - Humans MH - Liposomes/administration & dosage MH - Male MH - Melanoma/*drug therapy/secondary MH - Middle Aged MH - Neoplasm Metastasis MH - Pilot Projects MH - Skin Neoplasms/*drug therapy/pathology MH - Tomography, X-Ray Computed MH - Vincristine/*administration & dosage EDAT- 2008/11/18 09:00 MHDA- 2009/09/02 06:00 CRDT- 2008/11/18 09:00 PHST- 2008/11/18 09:00 [pubmed] PHST- 2009/09/02 06:00 [medline] PHST- 2008/11/18 09:00 [entrez] AID - 00008390-200812000-00004 [pii] AID - 10.1097/CMR.0b013e328311aaa1 [doi] PST - ppublish SO - Melanoma Res. 2008 Dec;18(6):400-4. doi: 10.1097/CMR.0b013e328311aaa1.