Radiation Oncology/RTOG Trials/7928

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RTOG 79-28 (LIVER)

  • Title: Phase I-II Study of Combined Modality Treatment of Primary Liver Cancer with Isotopic Immunoglobulin, Liver Irradiation, and ADR/5-FU
  • Objective:
    • I. Determine the therapeutic efficacy of combining administration of radiolabeled anti-CEA or anti-ferritin with whole liver radiotherapy plus combination chemotherapy using adriamycin/5-fluorouracil in patients with primary liver cancer.
    • II. Determine the maximal tolerated dose of radiolabeled antibody and the toxicities associated with this treatment.
    • III. Determine the dose distributions of anti-CEA and anti-ferritin in the tumor and in the entire body and compare the dose distributions of the 2 antibodies in hepatoma.
  • Protocol:
    • Nonrandomized study. Following treatment on Regimens A and B, patients with hepatic biliary carcinoma are entered to Arm I and patients with hepatoma to Arm I or Arm II.
    • Regimen A: Adriamycin/5-FU + whole liver RT
    • Regimen B: Adriamycin/5-FU
    • Arm I: I-131-labeled anti-CEA.
    • Arm II: I-131-labeled anti-ferritin.
    • Maintenance: Adriamycin/5-FU
  • Eligibility: Histologically documented primary hepatic malignancy who have measurable or evaluable disease.
  • Enrolled:
  • Conclusion:
    • PMID 6275989 -- Phase I-II study of isotopic immunoglobulin therapy for primary liver cancer. (Ettinger DS, Cancer Treat Rep. 1982 Feb;66(2):289-97.) Conclusion: "Present results suggest that further clinical studies with isotopic immunoglobulin are indicated."
  • Publications:
    • PMID 2998178 -- Computed tomography assisted volumetric analysis of primary liver tumor as a measure of response to therapy. (Ettinger DS, Am J Clin Oncol. 1985 Oct;8(5):413-8.) Conclusion: "In spite of small changes in total liver volume, there may be concomitantly substantial changes in tumor volume.
    • PMID 6085756 -- Comparative tumor dose from 131I-labeled polyclonal anti-ferritin, anti-AFP, and anti-CEA in primary liver cancers. (Leichner PK, Cancer Drug Deliv. 1984 Fall;1(4):321-8.)
    • PMID 6307515 -- Dosimetry of 131I-labeled antiferritin in hepatoma: specific activities in the tumor and liver. (Leichner PK, Cancer Treat Rep. 1983 Jul-Aug;67(7-8):647-58.) Conclusion: "These data, in conjunction with toxicity studies and tumor effective half-life measurements, led to the present treatment regimen of administering 30 mCi of polyclonal antiferritin IgG on Day 0 and 20 mCi on Day 5 following the first injection."
    • PMID 6275989 -- Phase I-II study of isotopic immunoglobulin therapy for primary liver cancer. (Ettinger DS, Cancer Treat Rep. 1982 Feb;66(2):289-97.) Conclusion: "Present results suggest that further clinical studies with isotopic immunoglobulin are indicated."
    • PMID 6268576 -- Dosimetry of 131I-labeled anti-ferritin in hepatoma: a model for radioimmunoglobulin dosimetry. (Leichner PK, Int J Radiat Oncol Biol Phys. 1981 Mar;7(3):323-33.)