Status:
COMPLETED
An Open Protocol for the Compassionate Use of Thalidomide
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 differ...
Detailed Description
Angiogenesis is a normal, physiological process in the growing embryo, wound healing and ovulation. Progressive recruitments of blood vessels to the tumor site are thought to result in a self perpetua...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00081757
Start Date
September 1 1998
End Date
May 1 2005
Last Update
July 2 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205