Completed

An Open Protocol For The Compassionate Use of Thalidomide For Patients With Advanced Or Refractory Malignancies

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What is being tested

Data Collection

Who is being recruted

Blood Protein Disorders
+11

+ Cardiovascular Diseases
+ Hematologic Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: September 1998
See protocol details

Summary

Principal SponsorUniversity of Arkansas
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 1998Actual date on which the first participant was enrolled.

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.

Official TitleAn Open Protocol For The Compassionate Use of Thalidomide For Patients With Advanced Or Refractory Malignancies 
NCT00081757
Principal SponsorUniversity of Arkansas
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
250 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Hemostatic Disorders
Neoplasms, Plasma Cell
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Arkansas for Medical Sciences/MIRTLittle Rock, United StatesSee the location
CompletedOne Study Center