Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study.

M. Sznol, R. G. Steis, J. W. Smith, J. E. Janik, W. H. Sharfman, W. J. Urba, R. G. Fenton, S. P. Creekmore, J. Beveridge, D. L. Longo

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

OBJECTIVE: Based upon their individual clinical activity and combined effects in animal models or in vitro, we wished to evaluate a regimen of cisplatin, interferon-alpha, and IL-2 in patients with metastatic melanoma. DESIGN: Phase II pilot study. SETTING: Referral-based US Government clinical research unit. PATIENTS: Nine patients with metastatic malignant melanoma. INTERVENTION: Cisplatin 75-100 mg/m2 was administered intravenously over 30 minutes on days 1 and 8. Interferon-alpha 2a 5 Mu/m2 body surface area (BSA) was given subcutaneously for 4 days beginning 1 day before each dose of cisplatin. Beginning on day 15 and day 22, IL-2 was administered by intravenous continuous infusion at 3 Mu/m2 BSA/d for 96 hours and by daily intravenous bolus concurrent with daily subcutaneous doses of interferon-alpha 2a. MAIN OUTCOME MEASURES: Antitumor response and toxicities. RESULTS: The study was stopped due to renal and hematopoietic toxicity and severe, delayed nausea and vomiting associated with the cisplatin-interferon treatment. Three of 9 patients achieved a partial response (duration 2.5, 4, 14+ months), and an additional patient had a 50% reduction in measurable tumor volume before undergoing resection of residual disease. Overall response rate was 45%. CONCLUSION: This regimen was associated with excessive toxicity, and the lack of complete responses in a patient cohort with favorable characteristics for response (good performance status, predominance of skin and lymph node metastatic sites) suggests that it had no advantage over less toxic treatment regimens. REGISTRATION: National Cancer Institute/Cancer Therapy Evaluation Program T89-0137.

Original languageEnglish (US)
JournalThe Online journal of current clinical trials [electronic resource]
VolumeDoc No 9
StatePublished - Jul 1 1992

Fingerprint

Cisplatin
Interleukin-2
Melanoma
Body Surface Area
Interferon-alpha
Therapeutics
National Cancer Institute (U.S.)
Poisons
Program Evaluation
Tumor Burden
Intravenous Infusions
Nausea
Interferons
Vomiting
Referral and Consultation
Animal Models
Lymph Nodes
interferon alfa-2a
Kidney
Skin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study. / Sznol, M.; Steis, R. G.; Smith, J. W.; Janik, J. E.; Sharfman, W. H.; Urba, W. J.; Fenton, R. G.; Creekmore, S. P.; Beveridge, J.; Longo, D. L.

In: The Online journal of current clinical trials [electronic resource], Vol. Doc No 9, 01.07.1992.

Research output: Contribution to journalArticle

Sznol, M, Steis, RG, Smith, JW, Janik, JE, Sharfman, WH, Urba, WJ, Fenton, RG, Creekmore, SP, Beveridge, J & Longo, DL 1992, 'Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study.', The Online journal of current clinical trials [electronic resource], vol. Doc No 9.
Sznol, M. ; Steis, R. G. ; Smith, J. W. ; Janik, J. E. ; Sharfman, W. H. ; Urba, W. J. ; Fenton, R. G. ; Creekmore, S. P. ; Beveridge, J. ; Longo, D. L. / Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study. In: The Online journal of current clinical trials [electronic resource]. 1992 ; Vol. Doc No 9.
@article{74941780c1ca47549703e00d75bd28fe,
title = "Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study.",
abstract = "OBJECTIVE: Based upon their individual clinical activity and combined effects in animal models or in vitro, we wished to evaluate a regimen of cisplatin, interferon-alpha, and IL-2 in patients with metastatic melanoma. DESIGN: Phase II pilot study. SETTING: Referral-based US Government clinical research unit. PATIENTS: Nine patients with metastatic malignant melanoma. INTERVENTION: Cisplatin 75-100 mg/m2 was administered intravenously over 30 minutes on days 1 and 8. Interferon-alpha 2a 5 Mu/m2 body surface area (BSA) was given subcutaneously for 4 days beginning 1 day before each dose of cisplatin. Beginning on day 15 and day 22, IL-2 was administered by intravenous continuous infusion at 3 Mu/m2 BSA/d for 96 hours and by daily intravenous bolus concurrent with daily subcutaneous doses of interferon-alpha 2a. MAIN OUTCOME MEASURES: Antitumor response and toxicities. RESULTS: The study was stopped due to renal and hematopoietic toxicity and severe, delayed nausea and vomiting associated with the cisplatin-interferon treatment. Three of 9 patients achieved a partial response (duration 2.5, 4, 14+ months), and an additional patient had a 50{\%} reduction in measurable tumor volume before undergoing resection of residual disease. Overall response rate was 45{\%}. CONCLUSION: This regimen was associated with excessive toxicity, and the lack of complete responses in a patient cohort with favorable characteristics for response (good performance status, predominance of skin and lymph node metastatic sites) suggests that it had no advantage over less toxic treatment regimens. REGISTRATION: National Cancer Institute/Cancer Therapy Evaluation Program T89-0137.",
author = "M. Sznol and Steis, {R. G.} and Smith, {J. W.} and Janik, {J. E.} and Sharfman, {W. H.} and Urba, {W. J.} and Fenton, {R. G.} and Creekmore, {S. P.} and J. Beveridge and Longo, {D. L.}",
year = "1992",
month = "7",
day = "1",
language = "English (US)",
volume = "Doc No 9",
journal = "The Online journal of current clinical trials",
issn = "1059-2725",
publisher = "Chapman And Hall",

}

TY - JOUR

T1 - Intensive therapy with cisplatin, interleukin-2 and interferon-alpha-2a in patients with metastatic melanoma. A phase II Study.

AU - Sznol, M.

AU - Steis, R. G.

AU - Smith, J. W.

AU - Janik, J. E.

AU - Sharfman, W. H.

AU - Urba, W. J.

AU - Fenton, R. G.

AU - Creekmore, S. P.

AU - Beveridge, J.

AU - Longo, D. L.

PY - 1992/7/1

Y1 - 1992/7/1

N2 - OBJECTIVE: Based upon their individual clinical activity and combined effects in animal models or in vitro, we wished to evaluate a regimen of cisplatin, interferon-alpha, and IL-2 in patients with metastatic melanoma. DESIGN: Phase II pilot study. SETTING: Referral-based US Government clinical research unit. PATIENTS: Nine patients with metastatic malignant melanoma. INTERVENTION: Cisplatin 75-100 mg/m2 was administered intravenously over 30 minutes on days 1 and 8. Interferon-alpha 2a 5 Mu/m2 body surface area (BSA) was given subcutaneously for 4 days beginning 1 day before each dose of cisplatin. Beginning on day 15 and day 22, IL-2 was administered by intravenous continuous infusion at 3 Mu/m2 BSA/d for 96 hours and by daily intravenous bolus concurrent with daily subcutaneous doses of interferon-alpha 2a. MAIN OUTCOME MEASURES: Antitumor response and toxicities. RESULTS: The study was stopped due to renal and hematopoietic toxicity and severe, delayed nausea and vomiting associated with the cisplatin-interferon treatment. Three of 9 patients achieved a partial response (duration 2.5, 4, 14+ months), and an additional patient had a 50% reduction in measurable tumor volume before undergoing resection of residual disease. Overall response rate was 45%. CONCLUSION: This regimen was associated with excessive toxicity, and the lack of complete responses in a patient cohort with favorable characteristics for response (good performance status, predominance of skin and lymph node metastatic sites) suggests that it had no advantage over less toxic treatment regimens. REGISTRATION: National Cancer Institute/Cancer Therapy Evaluation Program T89-0137.

AB - OBJECTIVE: Based upon their individual clinical activity and combined effects in animal models or in vitro, we wished to evaluate a regimen of cisplatin, interferon-alpha, and IL-2 in patients with metastatic melanoma. DESIGN: Phase II pilot study. SETTING: Referral-based US Government clinical research unit. PATIENTS: Nine patients with metastatic malignant melanoma. INTERVENTION: Cisplatin 75-100 mg/m2 was administered intravenously over 30 minutes on days 1 and 8. Interferon-alpha 2a 5 Mu/m2 body surface area (BSA) was given subcutaneously for 4 days beginning 1 day before each dose of cisplatin. Beginning on day 15 and day 22, IL-2 was administered by intravenous continuous infusion at 3 Mu/m2 BSA/d for 96 hours and by daily intravenous bolus concurrent with daily subcutaneous doses of interferon-alpha 2a. MAIN OUTCOME MEASURES: Antitumor response and toxicities. RESULTS: The study was stopped due to renal and hematopoietic toxicity and severe, delayed nausea and vomiting associated with the cisplatin-interferon treatment. Three of 9 patients achieved a partial response (duration 2.5, 4, 14+ months), and an additional patient had a 50% reduction in measurable tumor volume before undergoing resection of residual disease. Overall response rate was 45%. CONCLUSION: This regimen was associated with excessive toxicity, and the lack of complete responses in a patient cohort with favorable characteristics for response (good performance status, predominance of skin and lymph node metastatic sites) suggests that it had no advantage over less toxic treatment regimens. REGISTRATION: National Cancer Institute/Cancer Therapy Evaluation Program T89-0137.

UR - http://www.scopus.com/inward/record.url?scp=0026884220&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0026884220&partnerID=8YFLogxK

M3 - Article

C2 - 1343617

AN - SCOPUS:0026884220

VL - Doc No 9

JO - The Online journal of current clinical trials

JF - The Online journal of current clinical trials

SN - 1059-2725

ER -