Spots Global Cancer Trial Database for 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

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Trial Identification

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

Official Title: Phase II Trial of Chemoimmunotherapy With 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

Study ID: NCT01658813

Conditions

Gastrointestinal Cancer Metastatic

Renal Cell Cancer Metastatic

Non Small Cell Lung Cancer Metastatic

Interventions

5-Fluorouracil and Interferon

Study Description

Brief 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.

Detailed Description: Interferon with continuous infusion 5-Fluorouracil (5-FU) regimens have shown response rates ranging from 0-43% in various cancers. Monthly bolus 5-FU + interferon-alfa-2b has not undergone formal phase II testing. In a small pilot study, a 5 consecutive day schedule of 5-FU and interferon-alfa-2b resulted in the limiting toxicities of diarrhea and mucositis. A more limited schedule was recommended. Therefore, it is reasonable to examine such a schedule. In the current study, 5-FU will be followed by interferon-alfa-2b daily for 3 days to attempt to benefit from both the biochemical and immunologic mechanisms described above.