An Open Protocol for the Compassionate Use of Thalidomide

Phase 1

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00081757
• Lead Sponsor: University of Arkansas

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 different cancers respond and what kind of side effects patients will experience.

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 perpetuating loop helping to drive the growth of tumors. This new vasculature also allows competent tumor cells to find access to the vascular system and facilitate distant spread of tumor cells. Neovascularization is apparently an absolute prerequisite for physical expansion of solid tumors to grow beyond the volume of about 1-2 mm in diameter. Several molecular and cellular mechanisms have been identified by which tumor parenchyma may exert its angiogenic effect on host endothelial cells. There is also evidence that endothelial cells themselves, like other stromal cells, may act reciprocally to alter the behavior of adjacent tumor cells in a paracrine or cell contact mediated fashion. There is now known to be a diverse family of angiogenic growth factors, foremost among them being basic FGF and VEGF. Several angiogenic peptide genes have been sequenced and cloned. The degree of vascularization has acquired importance as an independent prognostic indicator in various types of solid tumors. More recently, it has been noted that increased angiogenesis may also be an important feature in hematologic malignancies, e.g. leukemia.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 2004-04-19
• Study First Submitted QC: 2004-04-21
• Study First Posted: 2004-04-22
• Study Completion: 2005-05
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-01
• Last Update Posted: 2010-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to use thalidomide to treat patients with advanced and/or refractory malignancies as part of a defined treatment protocol.

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to collect further basic safety and efficacy data.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences/MIRT; 🇺🇸 Little Rock, Arkansas, United States