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Phase I Study of P-30 Protein Administered by Weekly Intravenous Bolus Injections in Patients with Cancer (Summary Last Modified 02/91)
Basic Trial Information
Objectives I. Determine the toxicity and potential biological effects of single intravenous doses of P-30 protein administered weekly in patients with malignant disease. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients at least 21 years of age with histologically confirmed malignancy other than lymphoma or leukemia who have failed appropriate conventional therapy; patients who refuse conventional therapy are not eligible. Measurable disease is desired but not required. There must have been no prior therapy with biological response modifiers including interferons, interleukins, and tumor necrosis factor. At least 4 weeks must have elapsed since prior surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin or nitrosoureas), and patients must have recovered from the toxic effects of prior therapy (no toxicity greater than grade I). Patients with potentially hormone-responsive malignancies such as breast or prostate carcinoma must be off hormonal therapy at least 3 days prior to initiation of protocol therapy (these patients are evaluable for toxicity but not for response). An ECOG performance status of 0 or 1 (Karnofsky 80-100%) and a life expectancy of at least 3 months are required, as is adequate organ function demonstrated as follows: WBC at least 3,500, platelets at least 100,000, creatinine no more than 2 x the upper limit of normal, and SGOT and bilirubin no more than 2 x the upper limits of normal. Patients with symptomatic cardiovascular disease (i.e., NYHA class II-IV disease), congestive heart failure, angina pectoris, arrhythmia, and uncontrolled hypertension are ineligible. Serious active infections must be resolved prior to entry, and patients must be HBsAg negative. The following conditions also exclude: a requirement for systemic corticosteroids; psychiatric disorder or neurologic disease including brain metastases, seizure disorders, and leptomeningeal disease; prior organ allograft; significant metabolic abnormalities including uncontrolled diabetes mellitus, significant electrolyte abnormalities, and any degree of metabolic acidosis; any hemostasis impairment such as bleeding disorder or coagulation abnormality; and severe anorexia or grade III/IV nausea or vomiting. Patients who cannot cooperate because of senility or emotional instability are ineligible. Fertile women must use effective contraceptives; pregnant and lactating women are ineligible. Expected Enrollment 3-5 patients will be entered at each dose studied. Outline Nonrandomized study. Single-Agent Chemotherapy. P-30 Protein. Trial Lead Organizations Thompson Cancer Survival Center
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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