SWOG clinical trial number
S0008
Phase III Trial of High Dose Interferon Alpha-2b versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients with High Risk Melanoma
Abbreviated Title
High Dose IFN vs. Cis/Vinblastine/DTIC + IL-2 & IFN in High Risk Melanoma
Participants
NCORP,
Members, Medical Oncologists, Surgeons, Pathologists, ECOG, COG, US INSTITUTIONS ONLY
Treatment
Cisplatin
Alpha Interferon
DTIC
Interleukin-2
Vinblastine Sulfate
Surgery
Only pts w/melanoma of cutaneous origin or of unknown primary are eligible; PTs w/distant mets are not eligible; Pts w/melanoma of ocular, mucosal, or other non-cutaneous origin are not eligible; all pts w/newly diagnosed melanoma or a previously diagnosed primary now with subsequent, clinical, regional nodal disease and/or satellite in-transit disease must fulfill at least one of the criteria outlined in Section 5.1a-c as well as meet the staging criteria outlined in Section 4.0; all pts w/recurrent disease are eligible if there is recurrent disease in the regional nodal basin of a previously complete lymphadenectomy; Pts are eligible for this trial at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit or recurrent disease in prior lymphadenectomy basin; nodal, satellite/in-transit metastasis or recurrent disease in prior complete lymphadenectomy basin must have been confirmed histologically by H & E stained slides; Pts w/multiple regional nodal basin involvement are permitted as long as they are the appropriate anatomic drainage basins for the primary site; gross or microscopic extracapsular nodal extension is permitted; Pts at initial presentation of melanoma must meet all criteria in Section 5.4 and Appendix 19.1; No prior RT, chemo (including infusion or perfusion therapy), or any immunotherapy w/IFN and/or interleukins for any type of cancer (except post-lumpectomy radiation for breast cancer); Pts must have adequate hepatic function as outlined in Section 5.6; AGC > = 1,500/ul and PLT > = 100,000/ul; serum creatinine < & 1.5 mg/dl or calc creatinine > = 75 cc/min; Pts must not have evidence of symptomatic congestive heart failure, symptoms of coronary artery dz, serious cardiac arrhythmia, or prior MI on EKG; Pts must not have evidence of symptomatic pulmonary disease; PFT's must show a FEV1 > 2.0 L or > = 75% of predicted required for pts. over 50 or with history of pulmonary symptoms; Pts must not have autoimmune disorders, conditions of immunosuppression or treatment with systemic corticosteroids; Pts known to be recently PCR+ for hepatitis are not eligible; Pts must be willing/able to discontinue all antihypertensive meds only if randomized to Arm 2 per Section 5.13; Zubrod PS 0-1; Pts must not be planning to receive concomitant other bio therapy, RT, hormonal, chemo, surgery or other therapy while on this study; Pts registered by Adult Cooperative Groups must be 18 yrs. of age or older; Pts registered via the COG must be between 10 and 18 yrs. of age; Pts registered by Adult Cooperative Groups on 5-15-03 or later must be willing to participate in minimal residual disease (MRD) studies as outlined in Section 15.0; Pts registered by Adult Cooperative Groups prior to 5-15-03, should be offered participation in the MRD studies; Pts registered via the COG are encouraged, but not required to participate in the MRD studies as outlined in Section 15.0.
2014
Future perspectives in melanoma research: meeting report from the "Melanoma Bridge", Napoli, December 5th-8th 2013
PA Ascierto;AM Grimaldi;A Carrizosa Anderson;C Bifulco;A Cochran;C Garbe;AM Eggermont;M Faries;S Ferrone;J Gershenwald;TF Gajewski;R Halaban;FS Hodi;R Kefford;JM Kirkwood;J Larkin;S Leachman;M Maio;R Marais;G Masucci;I Melero;G Palmieri;A Puzanov;A Ribas;Y Saenger;B Schilling;B Seliger;D Stroncek;R Sullivan;A Testori;E Wang;G Ciliberto;N Mozzillo;FM Marincola;M Thurin Journal of Translational Medicine Oct 28;12(1):277
PMid: PMID25348889 | PMC number: PMC4232645
2013
Future perspectives in melanoma research:Meeting report from the "Melanoma Bridge. Napoli, December 2nd-4th 2012"
PA Ascierto;AM Grimaldi;N Acquavella;L Borgognoni;L Calabro;N Cascinelli;A Cesano;M Del Vecchio;AM Eggermont;M Faries;S Ferrone;BA Fox;T Gajewski;J Galon;S Gnjatic;H Gogas;M Kashani-Sabet;HL Kaufman;J Larkin;RS Lo;A Mantovani;K Margolin;C Melief;G McArthur;G Palmieri;I Puzanov;A Ribas;B Seliger;J Sosman;P Suenaert;A Tarhini;G Trinchieri;F Vidal-Vanaclocha;E Wang;G Ciliberto;N Mozzillo;FM Marincola;M Thurin Journal of Translational Medicine 11:137
PMid: PMID23731854 | PMC number: PMC3681569
2012
Phase III trial of high dose interferon alpha- 2b versus cisplatin, vinblastine, DTIC plus IL2 and interferon in patients with high risk melanoma (SWOG S0008): an intergroup study of CALGB, COG, ECOG and SWOG.
L Flaherty;J Moon;M Atkins;R Tuthill;J Thompson;JT Vetto;FG Haluska;A Pappo;JA Sosman;B Redman;A Ribas;JM Kirkwood;V Sondak J Clin Oncol 30 (suppl;abstr 8504); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral presentation;
CNS metastases as a site of progression on SWOG intergroup study S0008: a phase III trial of high dose interferon alpha-2b versus cisplatin, vinblastine, CTIC plus IL-2 and interferon in patients with high risk melanoma
W Samlowski;J Moon;M Witter;M Atkins;J Kirkwood;M Othus;A Ribas;V Sondak;L Flaherty J Clin Oncol 30 (suppl; abstr 8527); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), poster discussion;
2010
Should unknown primary melanomas be excluded from adjuvant therapy trials? Insights from the SWOG S0008 phase III randomized adjuvant trial
V Sondak;R Tuthill;J Moon;JA Thompson;C Lao;B Redman;LE Flaherty Journal of Clinical Oncology 28:7s (suppl; abstr 8517) ASCO 2010 Meeting; poster
Evaluation of minimal residual disease (MRD) in peripheral blood (PB) assessed prospectively by RT-PCR for melanoma-associated genes is an independent prognostic factor for survival in stage III melanoma (mel) patients (pts) enrolled onto an intergroup adjuvant trial S0008
J Sosman;J Moon;PY Liu;L Flaherty;MB Atkins;K Margolin;J Kirkwood;V Sondak Journal of Clinical Oncology 28:7s (suppl; abstr 8513); ASCO 2010 Meeting; poster
