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 Treatment Completed 15 to 80 NCI NCI-88-C-0003B NCI-T88-0020N, T88-0020

Objectives

I.  Assess the results of treatment with iododeoxyuridine as a radiosensitizer 
with concomitant radiotherapy in patients with gross residual cancers that are 
not being studied on disease-oriented protocols at the NCI.

II.  Compare the results with historical controls, emphasizing local control 
and survival.

III.  Obtain biopsies after infusion to allow for cell kinetic quantification 
using flow cytometric techniques and thymidine replacement estimates in 
selected patients whose tumors are accessible to biopsy.

Entry Criteria

Disease Characteristics:

Biopsy-proven neoplasm not currently under study on disease-
oriented protocols at the NCI

  Esophageal cancer or disease with hematogenous metastases
  that require treatment to the primary site allowed

  Breast cancer excluded

  Tumors considered radiosensitive (e.g., lymphomas and various
  pediatric neoplasms) excluded

  Sarcoma patients eligible for other NCI protocols excluded

Evidence of gross tumor mass required

  Lymphatic metastases allowed

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  Prior chemotherapy allowed

Endocrine therapy:
  Not specified

Radiotherapy:
  Prior radiotherapy to other sites allowed

Surgery:
  Not specified

Patient Characteristics:

Age:
  15 to 80

Performance status:
  Not specified

Hematopoietic:
  Adequate hematologic function required

Hepatic:
  Adequate hepatic function required

Renal:
  Adequate renal function required

Other:
  No known allergy to iodine
  No second malignancy within 5 years except basal cell skin
     carcinoma

Expected Enrollment

150 patients will be required.  If 25 patients per year are entered, no more 
than 6 years should be required for accrual.

Outline

Nonrandomized study.

Single-Agent Radiosensitization plus Radiotherapy.  Iododeoxyuridine, 
Idoxuridine, IUdR, NSC-39661; plus tumor irradiation using 4 or 10 MeV photons 
and (under selected conditions, depending on tumor location) electrons up to 
20 MeV in energy.

Goffman TE, Dachowski LJ, Bobo H, et al.: Long-term follow-up on National Cancer Institute Phase I/II study of glioblastoma multiforme treated with iododeoxyuridine and hyperfractionated irradiation. J Clin Oncol 10 (2): 264-8, 1992.[PUBMED Abstract]

Goffman TE, Raubitschek A, Mitchell JB, et al.: The emerging biology of modern radiation oncology. Cancer Res 50 (24): 7735-44, 1990.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Laurie L. Herscher, MD, Protocol chair(Contact information may not be current)		Ph: 301-496-5457