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A low rate of central nervous system progression in a phase II trial of outpatient chemobiologic therapy with cisplatin, temozolomide, interleukin-2, and interferon alfa 2-B for metastatic malignant melanoma.

Publication ,  Journal Article
Ready, N; Aronson, F; Wanebo, H; Kennedy, T
Published in: Am J Clin Oncol
October 2005

The objective of this study was to evaluate an outpatient chemobiotherapy regimen for metastatic melanoma that included an agent with central nervous system (CNS) antitumor activity. Patients without prior therapy for metastatic disease received 20 mg/m2 cisplatin intravenously on days 1 through 4, 100 mg/m2 temozolomide orally on days 1 through 5, concurrent with 5 MIU/m2 interferon alfa 2-B subcutaneously on days 1 through 5 and 10 MIU/m2 interleukin-2 subcutaneously on days 1 and 6 MIU/m2 subcutaneously on days 2 through 4. Treatment was given every 21 days to a maximum of 6 cycles. Twenty-four patients were enrolled. Significant toxicities included grade 3 or 4 nausea/vomiting in 8 (33%) and electrolyte abnormalities in 9 (38%). There were no episodes of febrile neutropenia or treatment-related deaths. Of 21 evaluable patients, responses were 6 progressive disease, 10 stable disease (SD), 3 partial remission (PR), and 2 complete remission (CR) (response rate 5 of 21= 24%). Four patients with SD or PR had prolonged survivals (23, 24, 37+, and 39 months). The 2 patients with clinical or pathologic CR had durable remissions (42+ and 46+ months). Median survival based on intent to treat was 291 days. Of 21 evaluable patients, 3 progressed initially in the CNS and none of the 5 patients achieving PR/CR progressed initially in the CNS. This regimen had significant morbidity but was safely delivered in the outpatient setting. Objective responses, prolonged stable disease, and durable remissions indicate activity. There was a lower-than-expected rate of initial CNS progression.

Duke Scholars

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

October 2005

Volume

28

Issue

5

Start / End Page

479 / 484

Location

United States

Related Subject Headings

  • Temozolomide
  • Recombinant Proteins
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male
  • Interleukin-2
  • Interferon-alpha
  • Interferon alpha-2
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ready, N., Aronson, F., Wanebo, H., & Kennedy, T. (2005). A low rate of central nervous system progression in a phase II trial of outpatient chemobiologic therapy with cisplatin, temozolomide, interleukin-2, and interferon alfa 2-B for metastatic malignant melanoma. Am J Clin Oncol, 28(5), 479–484. https://doi.org/10.1097/01.coc.0000164006.72694.1b
Ready, Neal, Frederick Aronson, Harold Wanebo, and Theresa Kennedy. “A low rate of central nervous system progression in a phase II trial of outpatient chemobiologic therapy with cisplatin, temozolomide, interleukin-2, and interferon alfa 2-B for metastatic malignant melanoma.Am J Clin Oncol 28, no. 5 (October 2005): 479–84. https://doi.org/10.1097/01.coc.0000164006.72694.1b.

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

October 2005

Volume

28

Issue

5

Start / End Page

479 / 484

Location

United States

Related Subject Headings

  • Temozolomide
  • Recombinant Proteins
  • Oncology & Carcinogenesis
  • Middle Aged
  • Melanoma
  • Male
  • Interleukin-2
  • Interferon-alpha
  • Interferon alpha-2
  • Humans