Phase II Pilot Trial of Concurrent Biochemotherapy with Cisplatin, Vinblastine, Temozolomide (CVT), Interleukin-2 (IL-2) and Interferona-2b (IFN) in Patients with Metastatic Melanoma.
Michael B Atkins, Jared A Gollob, James W Mier, David F McDermott, Linda Tutin, Patricia Sorokin, Jeffrey A Sosman, Beth Israel Deaconess Medical Center, Boston, MA; Univ Illinois Chicago, Chicago, IL.
Presented at the American Society Of Clinical Oncology, 2001 Conference

Biochemotherapy(BCT)for metastatic melanoma (MM) is associated with a 40-50% response rate with 10-20% of patients(pts) achieving a complete response (CR). Half the responders will have their initial site of relapse within the central nervous system (CNS)(Mcdermott et al Clin Ca Res:6:2201, 2000). In an effort to reduce the frequency of CNS relapse in responding pts we tested a novel concurrent BCT regimen in which dacarbazine (DTIC) was replaced by T. Pts received CVT (iv C:20 mg/m2/d and V:1.2 mg/m2/d and oral T:150 mg/m2/d) d1-4 concurrent with IL-2(9 MIU/m2/d CIV d1-4) and IFN(5 MIU/m2/d sc d1-5,8,10,12). G-CSF(d6-15 or until ANC 10,000) was routinely provided. Treatment cycles were repeated at 21 day intervals for a maximum of 4 cycles. Tumor response was assessed after cycles 2 and 4, then every 3 months (mos). Brain MRIs were performed pretreatment, after cycle 4 and then at 3-month intervals.
RESULTS: Forty-eight pts (median age 53- range:23-70; M/F:32/16; ECOG PS 0/1:25/23) were enrolled between 10/98 and 8/2000. No pts received prior chemotherapy or IL-2; 19 (40%) had previously received IFN. A total of 146 treatment cycles were administered. Significant toxicities included: 2 deaths (malignant pericarditis with tamponade and a cardiac arrest in cycle 3 week 2) and 3 GI serious adverse events (pancreatitis, appendicitis, and UGI bleed). The exact relationship of these events to therapy is uncertain. No other non-hematologic grade 4 toxicities were observed. Tumor responses were seen in 20 pts (RR: 42%) with 6 CR (12.5%). Response duration ranged from 2-14 mos (median 4 mos) with 7 responses currently ongoing. Median survival was 9 mos. Fifteen pts remain alive 4-25 mos post enrollment. Most responding pts had systemic progression prior to any CNS metastases. Only 1 responding pt, to date, has had an initial CNS relapse.
CONCLUSION: This regimen appears to be active and reasonably well tolerated in pts with MM. The substitution of T for DTIC may reduce the incidence of isolated CNS relapse in MM pts responding to BCT. Supported by grants from Amgen, Schering and Chiron.

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