Title

Using Interferon Gamma to Treat Malignant Carcinoid Tumors That Have Spread and Are No Longer Treatable with Surgery or Radiation (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program

Purpose of the Study

Inteferon gamma has been shown in preliminary trials to slow the growth of some carcinoid cancer cells. The purpose of this study is to determine the safety, usefulness and side effects of interferon gamma in treating malignant carcinoid tumors.

Results

This study showed that interferon gamma does not have a significant anti-cancer effect in treating carcinoid tumors. Only 6.25 percent of patients in the study had a decrease in the size or extent of their tumor. The tumor stayed about the same in 58.3 percent and in 31.3 percent of patients, the disease progressed.

Conclusion

Interferon gamma has only minimal antitumor effects in carcinoid tumor. It should not be considered standard therapy, and there are currently no plans for future study.

Start Date

March 28, 1996

Stop Date

February 27, 1998

Number of Participating Patients

51

Eligibility Requirements

Patients were at least 18 years old, had measurable carcinoid tumors, had no bone or central nervous system disease, no previous chemotherapy or biological therapy and no recent radiation therapy or surgery.

Study Design

Patients received interferon gamma by injection under the skin each day for at least eight weeks. If after eight weeks their disease improved or stayed the same, they continued daily injections for as long as they were helped. Treatment was stopped if their condition became worse.

Side Effects

The most common side effects included lowering of blood counts, fever, fatigue, flu-like symptoms, nausea and vomiting.

References

Stuart K, Levy DE, Anderson T, Axiotis CA, Dutcher JP, Eisenberg A, Erban JK, Benson AB. Phase II Study of Interferon Gamma in Malignant Carcinoid Tumors (E9292): A Trial of the Eastern Cooperative Oncology Group. Invest New Drugs 2004 Jan;22(1):75-81. (E9292) [Manuscript published 1/15/2004]

National Cancer Institute Patient Summary

http://www.cancer.gov/clinical_trials/view_clinicaltrials.aspx?version=patient&cdrid=64596

Reviewed by

Keith Stuart, MD, Beth Israel Deaconess; Robert Catalano, PharmD, ECOG Regulatory Officer; Cheryl K. Rutledge, BSN, Indiana University Cancer Center; Mary Lou Smith, ECOG Patient Representative

Released July 27, 2005 (Revised July 19, 2006)