Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer
This trial is active, not recruiting.
|Condition||unspecified adult solid tumor, protocol specific|
|Treatments||antibody therapy, biological therapy, muromonab-cd3, cyclophosphamide|
|Phase||phase 1/phase 2|
|Sponsor||St. Vincent Medical Center - Los Angeles|
|Start date||June 1991|
|Trial identifier||NCT00002482, CDR0000077247, NCI-V90-0206, SVMC-ONC-121|
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer.
Male or female participants at least 18 years old.
DISEASE CHARACTERISTICS: Metastatic cancer considered incurable by standard therapy and for which no higher priority protocol is available Locally progressive primary brain tumors (e.g., astrocytoma, glioma) are also eligible Brain metastases allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-4 (poor performance status brain tumor patients specifically eligible) Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No history of adult asthma No emphysema No pulmonary insufficiency No pulmonary edema Other: No AIDS or positive HIV serology No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
|Official title||A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE|
|Description||OBJECTIVES: I. Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies. II. Perform serial immune monitoring on patients treated with this regimen. III. Identify any clinical responses produced by this regimen. OUTLINE: Biological Response Modifier Therapy with Suppressor Cell Inhibition. Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271. PROJECTED ACCRUAL: At least 9 evaluable patients per diagnostic category will be required initially; if any response is seen during the dose-finding portion of the study, a total of 24 patients with that diagnosis will be entered.|
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