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Phase II Study of IL-6 Administered by 120-Hour Continuous Intravenous Infusion in Patients with Advanced Renal Cell Carcinoma (Summary Last Modified 08/93)
Basic Trial Information
Objectives I. Determine the objective response rate to interleukin-6 administered as a 120-hour continuous intravenous infusion in patients with advanced renal cell carcinoma. II. Characterize further the toxicities of this treatment. Entry Criteria Disease Characteristics: Histologically confirmed advanced renal cell carcinoma (metastatic or surgically incurable) Bidimensionally measurable, previously unirradiated disease required No history of brain metastases Prior/Concurrent Therapy: No concurrent investigational treatment No concurrent treatment for cancer Biologic therapy: No prior IL-2 No other immunotherapy allowed except: Prior interferon alpha as adjuvant therapy Prior tumor vaccine as adjuvant therapy or for advanced disease At least 6 weeks since interferon alpha At least 6 weeks since tumor vaccine therapy Chemotherapy: No prior chemotherapy Endocrine therapy: One prior hormonal regimen allowed No concurrent corticosteroids Radiotherapy: Prior radiotherapy to a single site outside of the brain allowed At least 4 weeks since radiotherapy Surgery: Not specified Patient Characteristics: Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500 AGC at least 1,500 Platelets between 100,000 and 600,000 Hb at least 9 g/dl Hepatic: Bilirubin no more than 1.5 mg/dl SGOT/SGPT no more than 2 x ULN Alkaline phosphatase no more than 4 x ULN (unless further elevation is related to liver metastases) PT/PTT no more than 1.2 x ULN Albumin at least 3.0 g/dl No more than 2/3 of the liver parenchyma involved with tumor (on CT) Renal: Creatinine no more than 2.0 mg/dl Cardiovascular: No symptoms of coronary artery disease (including those controlled by medication) No MI within 6 months No CHF No chronic arrhythmia requiring treatment No peripheral artery insufficiency No hypertension for which antihypertensive medication cannot be safely discontinued prior to IL-6 treatment Pulmonary: No dyspnea at rest or with minimal or moderate exertion Other: Adequate peripheral venous access (or placement of a semipermanent venous access device) required No active infection requiring antibiotics within 1 week of therapy No diabetes mellitus requiring insulin or oral hypoglycemics No autoimmune disease except: Vitiligo Autoimmune thyroid disease No HIV positivity by ELISA and Western Blot No HBsAg positivity or chronic hepatitis C No organ allografts No seizure disorder controlled with medication No medical or psychiatric condition that would unacceptably reduce the safety of or impair delivery of the proposed treatment or preclude voluntary informed consent No second malignancy within 5 years except: Basal cell carcinoma Carcinoma in situ of the cervix Negative pregnancy test required of fertile women Adequate contraception required of fertile women Expected Enrollment Up to 30 patients will be accrued at a rate of 2-4 patients/month. If no response is seen in the first 14 patients, the study will be terminated. Outline Nonrandomized study. Biological Response Modifier Therapy. Interleukin-6 (Sandoz), IL-6, NSC-643497.Published Results Weiss GR, Margolin KA, Sznol M, et al.: A phase II trial of a 120-hour continuous intravenous (CIV) infusion of interleukin-6 (rHuIL-6) for metastatic renal cell carcinoma (RCC). [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-779, 248, 1994. Trial Lead Organizations NCI - Cancer Therapy Evaluation Program
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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