An Open Protocol for the Compassionate Use of Thalidomide

NCT00081757 | Completed Phase 1

• 1 other identifier: UARK 98-023
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Advanced; Refractory; Plasmacytoma; Myeloma Proteins

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

• Click here for more information about UAMS

MeSH Terms

Conditions

Multiple Myeloma; Plasmacytoma

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Athanasios Fassas, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2004
• First Posted: April 22, 2004
• Study Start: September 1, 1998
• Study Completion: May 1, 2005
• Last Updated: July 2, 2010

Record last verified: 2010-07

Locations

US (1)