5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the combination of a 5-Fluorouracil (5-FU) and interferon, which is able to stimulate the immune system to kill cancer cells, will help to increase tumor shrinkage in previously-treated metastatic gastrointestinal, kidney, or lung Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western Regional Medical Center
• Treatments: Fluorouracil; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• Patients must have histologically-proven, metastatic gastrointestinal, kidney, or lung cancer who have had disease progression on at least two prior systemic therapies.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.

• Patients must be felt to have recovered from effects of prior therapy, such as past expected white blood count nadir for chemotherapy (> 2 weeks for most agents, > 6 weeks for nitrosoureas or mitomycin-C)

• Patient consent must be obtained prior to entrance onto study.

• White blood count > 3500/mm3; platelet count of at least 100,000/mm3; hemoglobin > 9.0 gm/dl; bilirubin, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) less than 3 times the upper limit of normal; serum creatinine < 1.8.

• Corticosteroids and immunosuppressive agents are not permitted during the course of the study. Patients must have received no corticosteroids or immunosuppressive medications at least 2 weeks prior to entrance on-study.

• Patients with elevated temperatures > 100.5 degrees F, must have sources of occult infection excluded.

• Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment.

Exclusion Criteria:

• Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, or cerebrovascular accident.

• Prior history of psychiatric disorder that could be exacerbated by interferon therapy or which could preclude completion of this therapy.

• Pregnancy or lactation.

• History of hypersensitivity to interferon alfa or fluoropyrimidines.

• History of severe debilitating pulmonary disease, such as chronic obstructive pulmonary disease requiring continuous oxygen therapy.

• History of autoimmune disease requiring immunosuppression.

• Documented inflammatory joint or systemic inflammatory disease (such as Lupus) which could be exacerbated by interferon therapy.