Phase II trial of Serratia marcescens extract in recurrent malignant astrocytoma.

Abstract

Nineteen assessable patients with recurrent malignant astrocytomas who had failed standard therapy (surgery, radiation, and/or chemotherapy) were treated on a phase I-II trial with a biologic extract of Serratia marcescens (ImuVert; Cell Technology, Boulder, CO) a new biologic response modifier (BRM). Two complete responses (CRs) were seen, of 63 and 77+ weeks duration. One minor response (MR) occurred, of 6 weeks duration. There were four additional stable (S) patients, with durations of 58+, 39, 12, and 7 weeks. Median time to progression and median survival in the CR plus MR patients were 63 and 129+ weeks, respectively. Overall, median time to progression and median survival were 12 and 19 weeks, respectively. Three patients are alive greater than or equal to 2.5 years from study entry. Common toxicities included transient (less than 72 hours) tenderness, induration, and erythema at the injection sites. Systemic toxicities were less frequent and included fever, chills, nausea/vomiting, headache, arthralgia, and hypotension. The response rate (CR plus MR) to this new BRM is modest (16%). However, the observation of CRs in patients with advanced recurrent malignant astrocytomas, with acceptable overall toxicity, warrants further study of this agent.

Supra and Infra Tentorial Gliomas in Children

“…Passive immunotherapy with monoclonal antibodies has had its best success via intrathecal injection for meningeal tumor 28 . Restorative or nonspecific immunotherapy has been shown to have beneficial effects on tumor shrinkage (β‐interferon, 29 γ‐interferon, 30 and Imuvert 31 ). Combinations of these therapies with radiation and chemotherapy and with each other are being studied and are likely to be routes for the future.…”

Phase II trial of a new biological response modifier (ImuVert) in advanced prostate cancer

“…Furthermore, these early trials suggested that ImuVert has activity in several tumor types including prostate cancer [3,4]. Phase II studies have begun in several tumor types and preliminary results have demonstrated activity in gliomas [6]. For these reasons we initiated a Phase II trial in patients with metastatic prostatic cancer.…”

Immunotherapeutic Strategies for Malignant Glioma

“…54 One clinical trial performed in patients with recurrent malignant gliomas revealed a response rate of 16%. 55 In another study of ImuVert and concurrent radiation therapy, some toxicity in the form of hypotension was encountered, with survival similar to that of standard therapy in historical controls. 56 Along similar lines, immunization with a killed tumor cell vaccine modified with Newcastle disease virus has been reported to have an effect on tumors.…”