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Phase II trial of menogaril in non-Hodgkin's lymphomas: a Southwest Oncology Group trial.

AbstractPURPOSE:
To assess the efficacy and toxicity of menogaril against non-Hodgkin's lymphoma (NHL) in a group of previously treated patients.
PATIENTS AND METHODS:
Sixty-two eligible patients with a histologic diagnosis of NHL were enrolled, 35 of who had intermediate or high-grade histologies and 27 of who had low-grade lymphomas. Patients with intermediate or high-grade lymphomas had received only 1 prior chemotherapy regimen, while patients with low-grade histologies had received 1 or 2 prior chemotherapy regimens. Menogaril was administered at 160 mg/m2 intravenously over 1 hour, once every 28 days.
RESULTS:
Among the 35 patients with intermediate or high-grade lymphomas who were evaluable for response, 6 of 35 patients achieved a partial response (PR) for a response rate of 17% (95% confidence interval: 7%-34%). Median survival in this group of patients was 13 months. For those patients with low-grade lymphoma, 5 of 26 patients achieved a PR for a response rate of 19% (95% confidence interval: 6%-38%). No complete responses were observed in either patient group. The incidence of serious (grade 3 or 4) toxicity for those with intermediate/high-grade and low-grade lymphomas was 43% and 44%, respectively. Most of these toxic effects consisted of reversible myelosuppression. Menogaril was discontinued in 2 patients due to prolonged neutropenia. Cardiotoxicity was observed in 4 patients, requiring discontinuation of the drug in 1 patient. No treatment-related deaths occurred and the overall toxicity was felt to be acceptable.
CONCLUSION:
The observed antitumor activity of single agent menogaril against both intermediate/high-grade and low-grade lymphomas was modest. Further exploration of this agent in patients with non-Hodgkin's lymphomas does not seem warranted.
AuthorsD F Moore Jr, T D Brown, M LeBlanc, S Dahlberg, T P Miller, S McClure, R I Fisher
JournalInvestigational new drugs (Invest New Drugs) Vol. 17 Issue 2 Pg. 169-72 ( 1999) ISSN: 0167-6997 [Print] UNITED STATES
PMID10638487 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antibiotics, Antineoplastic
  • Menogaril
Topics
  • Aged
  • Antibiotics, Antineoplastic (adverse effects, therapeutic use)
  • Female
  • Humans
  • Lymphoma, Non-Hodgkin (drug therapy)
  • Male
  • Menogaril (adverse effects, therapeutic use)
  • Middle Aged
  • Neoplasm Staging
  • Patient Dropouts
  • Survival Rate
  • Treatment Outcome

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