Phase II trial of menogaril in non-Hodgkin's lymphomas: a Southwest Oncology Group trial.
OBJECTIVE
To assess the efficacy and toxicity of menogaril against non-Hodgkin's lymphoma (NHL) in a group of previously treated patients.


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.


CONCLUSIONS
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.
Moore
D F
DF
Wichita CCOP, KS, USA.
Brown
T D
TD
LeBlanc
M
M
Dahlberg
S
S
Miller
T P
TP
McClure
S
S
Fisher
R I
RI
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D017290:Menogaril / Q000009:adverse effects* / Q000627:therapeutic use*; D008875:Middle Aged; D009367:Neoplasm Staging; D010352:Patient Dropouts; D015996:Survival Rate; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D017290:Menogaril