Melanoma

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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.


Carboplatin (Paraplatin) & Paclitaxel (Taxol)

Regimen #1, Rao, et al. 2006

28-day cycles

Regimen #2, Rao, et al. 2006

21-day cycles

Regimen #3, Hauschild, et al. 2009

21-day cycles x 3 cycles, then

21-day cycles x 7 cycles

References

  1. Rao RD, Holtan SG, Ingle JN, Croghan GA, Kottschade LA, Creagan ET, Kaur JS, Pitot HC, Markovic SN. Combination of paclitaxel and carboplatin as second-line therapy for patients with metastatic melanoma. Cancer. 2006 Jan 15;106(2):375-82. link to original article contains verified protocol PubMed
  2. Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. Epub 2009 Apr 6. link to original article contains verified protocol PubMed

Carboplatin (Paraplatin), Paclitaxel (Taxol), Sorafenib (Nexavar)

Regimen

Please see the negative result reported by Flaherty, et al. 2010 for this regimen's overall survival as compared to Carboplatin (Paraplatin) & Paclitaxel (Taxol).

21-day cycles x 3 cycles, then

21-day cycles x up to 7 additional cycles; if stable disease or continued response, then

given until progression of disease or unacceptable toxicity

References

  1. S. S. Agarwala, U. Keilholz, D. Hogg, C. Robert, P. Hersey, A. Eggermont, S. Grabbe, R. Gonzalez, K. Patel, A. Hauschild. Randomized phase III study of paclitaxel plus carboplatin with or without sorafenib as second-line treatment in patients with advanced melanoma. 2007 ASCO Annual Meeting abstract 8510. link to abstract
  2. Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. Epub 2009 Apr 6. link to original article contains verified protocol PubMed
  3. K. T. Flaherty, S. J. Lee, L. M. Schuchter, L. E. Flaherty, J. J. Wright, P. D. Leming, J. M. Kirkwood. Final results of E2603: A double-blind, randomized phase III trial comparing carboplatin ©/paclitaxel (P) with or without sorafenib (S) in metastatic melanoma. 2010 ASCO Annual Meeting abstract 8511. link to abstract

Cisplatin (Platinol), Dacarbazine (DTIC) +/- Carmustine (BiCNU)

Regimen

21-day cycles x 6 cycles

References

  1. Ridolfi R, Chiarion-Sileni V, Guida M, Romanini A, Labianca R, Freschi A, Lo Re G, Nortilli R, Brugnara S, Vitali P, Nanni O; Italian Melanoma Intergroup. Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol. 2002 Mar 15;20(6):1600-7. link to original article contains verified protocol PubMed

Cisplatin (Platinol), Dacarbazine (DTIC), IL-2, IFN alfa-2b +/- Carmustine (BiCNU)

Regimen

21-day cycles x 6 cycles

References

  1. Ridolfi R, Chiarion-Sileni V, Guida M, Romanini A, Labianca R, Freschi A, Lo Re G, Nortilli R, Brugnara S, Vitali P, Nanni O; Italian Melanoma Intergroup. Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol. 2002 Mar 15;20(6):1600-7. link to original article contains verified protocol PubMed

Cisplatin (Platinol), Paclitaxel (Taxol), Dacarbazine (DTIC)

Regimen

References

  1. Papadopoulos NE, Bedikian A, Ring S, Kim KB, Hwu WJ, Gerber DL, Homsi J, Hwu P. Phase I/II Study of a Cisplatin-Taxol-Dacarbazine Regimen in Metastatic Melanoma. Am J Clin Oncol. 2009 Oct;32(5):509-14. link to original article contains protocol PubMed

CVD

CVD: Cisplatin, Vinblastine, Dacarbazine

Regimen #1, McDermott, et al. 2000 & Atkins, et al. 2008

21-day cycles x up to 4 cycles

Supportive medications:

Regimen #2, Eton, et al. 2002

6-week cycles x up to 5 cycles

References

  1. McDermott DF, Mier JW, Lawrence DP, van den Brink MR, Clancy MA, Rubin KM, Atkins MB. A phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin 2, and interferon alpha-2B in patients with metastatic melanoma. Clin Cancer Res. 2000 Jun;6(6):2201-8. link to original article contains verified protocol PubMed
  2. Eton O, Legha SS, Bedikian AY, Lee JJ, Buzaid AC, Hodges C, Ring SE, Papadopoulos NE, Plager C, East MJ, Zhan F, Benjamin RS. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2045-52. link to original article contains verified protocol PubMed content property of HemOnc.org
  3. Atkins MB, Hsu J, Lee S, Cohen GI, Flaherty LE, Sosman JA, Sondak VK, Kirkwood JM; Eastern Cooperative Oncology Group. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008 Dec 10;26(35):5748-54. Epub 2008 Nov 10. link to original article contains verified protocol PubMed

CVD, IL-2, IFN alfa-2b - sequential biochemotherapy

CVD: Cisplatin, Vinblastine, Dacarbazine

Regimen #1, McDermott, et al. 2000 & Atkins, et al. 2008

21-day cycles x up to 4 cycles

Supportive medications:

  • All antihypertensive therapy discontinued at least 24 hours before each cycle
  • Cephalexin (Keflex) or Ciprofloxacin (Cipro) 250 mg PO BID on days 1-14
  • Filgrastim (Neupogen) 5 mcg/kg SC on days 7-16, or until ANC >10,000
  • Ondansetron (Zofran) 32 mg IV daily
  • Lorazepam (Ativan) 1 mg PO/IV every 6 hours
  • Acetaminophen (Tylenol) 650 mg PO every 6 hours
  • Ranitidine (Zantac) 150 mg PO every 12 hours
  • Hydroxyzine (Atarax) 25-50 mg PO or Diphendyramine (Benadryl) 25 mg PO every 6 hours for pruritis
  • Meperidine (Demerol) 25-50 mg IV every 3 hours for chills and rigors
  • Antidiarrheals & anxiolytics as needed

Regimen #2, Eton, et al. 2002

6-week cycles x up to 5 cycles

References

  1. McDermott DF, Mier JW, Lawrence DP, van den Brink MR, Clancy MA, Rubin KM, Atkins MB. A phase II pilot trial of concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin 2, and interferon alpha-2B in patients with metastatic melanoma. Clin Cancer Res. 2000 Jun;6(6):2201-8. link to original article contains verified protocol PubMed
  2. Eton O, Legha SS, Bedikian AY, Lee JJ, Buzaid AC, Hodges C, Ring SE, Papadopoulos NE, Plager C, East MJ, Zhan F, Benjamin RS. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2045-52. link to original article contains verified protocol PubMed
  3. Atkins MB, Hsu J, Lee S, Cohen GI, Flaherty LE, Sosman JA, Sondak VK, Kirkwood JM; Eastern Cooperative Oncology Group. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008 Dec 10;26(35):5748-54. Epub 2008 Nov 10. link to original article contains verified protocol PubMed

Dacarbazine (DTIC)

Regimen #1, Robert, et al. 2011

21-day cycles x 8 cycles

Regimen #2, Chapman, et al. 2011

21-day cycles, given until progression of disease or unacceptable toxicity

Regimen #3, Middleton, et al. 2000

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, Gore M, Aamdal S, Cebon J, Coates A, Dreno B, Henz M, Schadendorf D, Kapp A, Weiss J, Fraass U, Statkevich P, Muller M, Thatcher N. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000 Jan;18(1):158-66. link to original article contains verified protocol PubMed
  2. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. Epub 2011 Jun 5. link to original article contains verified protocol PubMed
  3. Robert C, Thomas L, Bondarenko I, O'Day S, M D JW, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. Epub 2011 Jun 5. link to original article contains verified protocol PubMed

High-dose (HD) IL-2

Regimen

  • IL-2 - Aldesleukin (Proleukin) 600,000 or 720,000 units/kg IV every 8 hours x up to 14 doses per week, on days 1-5
    • After a 6-9 day rest period, another 14 doses per week given over 5 days is given as described above

6-12 weeks per cycle x up to 5 cycles

Supportive medications:

  • Included Acetaminophen (Tylenol), Indomethacin (Indocin), Meperidine (Demerol), Ranitidine (Zantac), Cimetidine (Tagamet), Hydroxyzine (Atarax), Diphendyramine (Benadryl), dopamine, phenylephrine, antidiarrheals, antiemetics, anxiolytics, diuretics, and, if needed, antibiotics.

References

  1. Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. link to original article contains verified protocol PubMed
  2. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S11-4. PubMed

IL-2 maintenance biotherapy

Regimen

Low-dose cycles 1, 4, 7, 9, 11:

28-day cycles x a total of 12 cycles after being combined with the pulse cycles below

Pulse cycles 2, 3, 5, 6, 8, 10, 12:

  • IL-2 - Aldesleukin (Proleukin) 18,000,000 units/m2 IV continuous infusion over 6 hours, then 18,000,000 units/m2 IV continuous infusion over 12 hours, then 18,000,000 units/m2 IV continuous infusion over 24 hours on days 1-2
  • Sargramostim (Leukine) 125 mcg/m2 SC on days 3-17 (note: this was possibly a typo in the regimen since shifting the schedule 2 days forward would be days 3-16)

28-day cycles x a total of 12 cycles after being combined with the low dose cycles above

Supportive medications:

  • Ondansetron (Zofran) 32 mg IV or Granisetron (Kytril) 2 mg IV daily
  • Omeprazole (Prilosec) 20 mg PO QPM
  • Acetaminophen (Tylenol) 650 mg PO every 4 hours, starting prior to IL-2 and continuing on days 1-2
  • Meperidine (Demerol) 25 mg IV every 6 hours as needed for chills and rigors

References

  1. O'Day SJ, Boasberg PD, Piro L, Kristedja TS, Wang HJ, Martin M, Deck R, Ames P, Shinn K, Kim H, Fournier P, Gammon G. Maintenance biotherapy for metastatic melanoma with interleukin-2 and granulocyte macrophage-colony stimulating factor improves survival for patients responding to induction concurrent biochemotherapy. Clin Cancer Res. 2002 Sep;8(9):2775-81. link to original article contains verified protocol PubMed

Ipilimumab (Yervoy)

Regimen #1, Hodi, et al. 2010

21-day cycles x 4 cycles

Regimen #2, Wolchok, et al. 2010

  • Ipilimumab (Yervoy) 10 mg/kg IV over 90 minutes on day 1
    • Lower doses including 3 mg/kg (the FDA approved dose) were investigated, but the 10 mg/kg dose was recommended in this study

21-day cycles x 4 cycles

Regimen #3, O'Day, et al. 2010

Induction phase:

21-day cycles x 4 cycles

Maintenance phase:

12-week cycles, given until progression of disease or unacceptable toxicity; starts 12 weeks after completion of induction phase

References

  1. Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbé C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. Epub 2009 Dec 8. link to original article contains verified protocol PubMed
  2. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbé C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. Epub 2010 Jun 5. link to original article contains verified protocol PubMed
  3. O'Day SJ, Maio M, Chiarion-Sileni V, Gajewski TF, Pehamberger H, Bondarenko IN, Queirolo P, Lundgren L, Mikhailov S, Roman L, Verschraegen C, Humphrey R, Ibrahim R, de Pril V, Hoos A, Wolchok JD. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol. 2010 Aug;21(8):1712-7. Epub 2010 Feb 10. link to original article contains verified protocol PubMed

Ipilimumab (Yervoy) & Dacarbazine (DTIC)

Regimen

Induction phase:

21-day cycles x 4 cycles, then

21-day cycles x 4 cycles; if patient has stable disease or objective response, proceed to maintenance phase

Maintenance phase:

12-week cycles, given until progression of disease or unacceptable toxicity

References

  1. Robert C, Thomas L, Bondarenko I, O'Day S, M D JW, Garbe C, Lebbe C, Baurain JF, Testori A, Grob JJ, Davidson N, Richards J, Maio M, Hauschild A, Miller WH Jr, Gascon P, Lotem M, Harmankaya K, Ibrahim R, Francis S, Chen TT, Humphrey R, Hoos A, Wolchok JD. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med. 2011 Jun 30;364(26):2517-26. Epub 2011 Jun 5. link to original article contains verified protocol PubMed

Temozolomide (Temodar)

Regimen

28-day cycles, given until progression of disease or unacceptable toxicity

References

  1. Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, Gore M, Aamdal S, Cebon J, Coates A, Dreno B, Henz M, Schadendorf D, Kapp A, Weiss J, Fraass U, Statkevich P, Muller M, Thatcher N. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000 Jan;18(1):158-66. link to original article contains verified protocol PubMed

Vemurafenib (Zelboraf)

Regimen

given until progression of disease or unacceptable toxicity

References

  1. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. Epub 2011 Jun 5. link to original article contains verified protocol PubMed
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