5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 21, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Western Regional Medical Center
- Interventions being studied
- Drug: 5-Fluorouracil and Interferon
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Western Regional Medical Center, IncGoodyear, Arizona
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 21, 2018. Always confirm current availability with the study team.