ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
An Open Protocol for the Compassionate Use of Thalidomide

This study has been completed.

Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00081757
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: Thalidomide
Phase I
Phase II

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Multiple Myeloma   

Drug Information available for:   Thalidomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:   An Open Protocol For The Compassionate Use of Thalidomide For Patients With Advanced Or Refractory Malignancies

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • 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:
  • The secondary objective of this study is to collect further basic safety and efficacy data.

Estimated Enrollment:   250
Study Start Date:   September 1998
Estimated Study Completion Date:   May 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081757

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT    
      Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators
University of Arkansas

Investigators
Principal Investigator:     Athanasios Fassas, MD     UAMS    
  More Information


Click here for more information about UAMS  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   UARK 98-023
First Received:   April 19, 2004
Last Updated:   July 11, 2005
ClinicalTrials.gov Identifier:   NCT00081757
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Advanced  
Refractory  
Plasmacytoma  
Myeloma Proteins  

Study placed in the following topic categories:
Immunoproliferative Disorders
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myeloma Proteins
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Plasmacytoma
Plasmacytoma anaplastic
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers