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

Phase 1/Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Athanasios Fassas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:

UARK 98-023



Start Date:

September 1998

Completion Date:

May 2005

Related Keywords:

  • Multiple Myeloma
  • Advanced
  • Refractory
  • Plasmacytoma
  • Myeloma Proteins
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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