Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	under 75	NCI	RTOG-8301 RTOG-83-01

Objectives

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.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

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.

Expected Enrollment

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.

Outline

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

Stanley Order, MD, ScD, FACR, Protocol chair		Ph: 516-222-5190