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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed over 18 MSKCC-94014 NCI-V94-0461

Objectives

I.  Examine tumor incorporation and metabolism of radioiodinated idoxuridine 
(125I-IUDR) injected into hepatic metastases from colorectal cancer using 
iodine-131 (131-I) for imaging.

II.  Evaluate the treatment potential of 125I-IUDR.

III.  Study normal tissue incorporation and catabolism of 125I/131I-IUDR.

IV.  Develop information for future studies of the optimum dose of 125I-IUDR 
for tumor targeting.

Entry Criteria

Disease Characteristics:

Histologically confirmed colorectal adenocarcinoma metastatic
to the liver
  Measurable hepatic metastases required
  Minimal extrahepatic disease allowed

Progression of hepatic disease following an hepatic arterial
regimen required

Adequate hepatic perfusion and no extrahepatic extravasation
demonstrated by technetium-99 scan within 4 weeks prior to
treatment

No ascites or hepatic encephalopathy

Ineligible for or patient has refused treatment on protocols of
higher priority

Prior/Concurrent Therapy:

Full recovery from hematologic and gastrointestinal toxicities
of prior therapy required

Biologic therapy:
  Not specified

Chemotherapy:
  At least 4 weeks since chemotherapy (6 weeks since mitomycin
  and nitrosoureas)

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 70-100%

Life expectancy:
  At least 8 weeks 

Hematopoietic:
  WBC at least 4,000
  Platelets at least 150,000

Hepatic:
  Bilirubin no greater than 2.0 mg/dl
  Albumin at least 2.5 g/dl

Renal:
  Creatinine no greater than 2.0 mg/dl

Other:
  No active infection
  No contraindication to MRI, CT, or SPECT scanning
  Negative pregnancy test in fertile women

Blood/body fluid analyses to determine eligibility completed
within 14 days prior to registration; baseline CT or other
imaging studies used to assess response of known tumor areas
completed within 28 days prior to treatment

Expected Enrollment

5 patients will be enrolled on this study.

Outline

Isotope Therapy.  Iodine-125 (125-I) with iodine-131 (131-I) for imaging 
carried on idoxuridine, IUDR, NSC-39661.

Macapinlac H, Kemeny N, Daghighian F, et al.: Molecular radiotherapy of hepatic metastases from colorectal cancer(CA) using hepatic arterial I-131/I-125-iododeoxyuridine (IUdR). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A-479, 200, 1995.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Nancy Kemeny, MD, Protocol chair		Ph: 212-639-8068; 800-525-2225