An Open Protocol for the Compassionate Use of Thalidomide

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the use of thalidomide for the treatment of cancer. Patients with many types of cancers will be enrolled because the researchers will also study how the different cancers respond and what kind of side effects patients will experience.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Thalidomide

Criteria

Inclusion Criteria

• All patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists.

• Patients must be 18 years of age or older. Women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter.

• Patients must sign an informed consent to participate in this study.

• SWOG Performance status 0-3, unless related to cancer pain.

• Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy.

• Pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy.

• Patients must have adequate hematologic function as demonstrated by total white blood count > or = 2000/mm3, adequate renal function as demonstrated by serum creatinine < or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin < or =1.5 mg/dl and transaminases < or =4 x ULN.

Exclusion Criteria

• Patients must not be eligible for any UAMS participating clinical trial of higher priority.