Phase I/II Escalating ADR/5-FU Integrated with Isotopic Immunoglobulin Following Radiotherapy plus ADR/5-FU for Liver Cancer
Basic Trial Information
|Phase II, Phase I||Treatment||Completed||under 75||NCI||RTOG-8301|
I. Provide the necessary data to determine the maximum safe dose of adriamycin and 5-fluorouracil that can be combined with I-131 antiferritin IgG (given 30 mCi on day 0 and 20 mCi on day 5). II. Determine whether 20 mCi I-131 anti-AFP plus 30 mCi antiferritin increases tumor dose deposition and offers advantage in tumor effective half-life and dose deposition over I-131 antiferritin alone. III. Combine the radiolabeled preparation considered best (on dosimetric grounds) with escalating doses of adriamycin and 5-fluorouracil. IV. Determine the best combination of adriamycin and 5-fluorouracil plus I-131 labeled antibody for Phase II trial in AFP and non-AFP hepatomas. V. Complete Phase II trials using physical exam and CT tumor volume reconstruction to determine the remission rate, duration of remission, and survival.
See General Eligibility Criteria
See General Eligibility Criteria
General Eligibility Criteria:
Patients less than 75 years of age with measurable or evaluable (on CT scan), histologically confirmed primary hepatic malignancy. Patients must have a Karnofsky performance status of greater than 30 prior to entry and a performance status of greater than 60 prior to immunoglobulin therapy. Bone marrow, hepatic, renal, and cardiac functions must be adequate; patients must be cleared of active infection. There may be no chemotherapy, major surgery, partial hepatectomy, or large field radiation therapy during the 28 days prior to entry. Protocol treatment may begin 2 weeks following exploratory laparotomy if recovery is uneventful.
Approximately 20 patients with AFP hepatoma and 15 patients with non-AFP disease are required for the Phase I portion of the study; 15-20 patients in each disease category will be required for the Phase II portion.
Nonrandomized study. Patients with non-AFP hepatoma enter Regimen A; those with AFP hepatoma enter Regimen B. Regimen A: Radiotherapy plus 2-Drug Chemotherapy plus Isotopic Therapy. Tumor irradiation using cobalt teletherapy or supervoltage equipment (2 MeV or greater); plus Adriamycin, ADR, NSC-123127; 5-Fluorouracil, 5-FU, NSC-19893; plus I-131 Antiferritin IgG. Regimen B: Radiotherapy plus 2-Drug Chemotherapy plus Isotopic Therapy. Tumor irradiation; plus ADR; 5-FU; plus I-131 Antiferritin IgG; plus I-131 anti-alpha fetoprotein, I-131 anti-AFP.
Stillwagon GB, Order SE, Klein JL, et al.: Multi-modality treatment of primary nonresectable intrahepatic cholangiocarcinoma with 131I anti-CEA--a Radiation Therapy Oncology Group Study. Int J Radiat Oncol Biol Phys 13 (5): 687-95, 1987.[PUBMED Abstract]
Ettinger DS, Leichner PK, Siegelman SS, et al.: Computed tomography assisted volumetric analysis of primary liver tumor as a measure of response to therapy. Am J Clin Oncol 8 (5): 413-8, 1985.[PUBMED Abstract]
Leichner PK, Klein JL, Fishman EK, et al.: Comparative tumor dose from 131I-labeled polyclonal anti-ferritin, anti-AFP, and anti-CEA in primary liver cancers. Cancer Drug Deliv 1 (4): 321-8, 1984 Fall.[PUBMED Abstract]
Epstein BE, Pajak TF, Haulk TL, et al.: Metastatic nonresectable fibrolamellar hepatoma: prognostic features and natural history. Am J Clin Oncol 22 (1): 22-8, 1999.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Radiation Therapy Oncology Group
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.