Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033709
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 6, 2014
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with thalidomide in treating patients who have metastatic, locally advanced, or unresectable leiomyosarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: temozolomide Drug: thalidomide Phase 2

Detailed Description:


  • Determine the efficacy of temozolomide and thalidomide in patients with metastatic, locally advanced, or unresectable leiomyosarcoma.
  • Determine the time to progression in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the clinical and laboratory toxic effects and tolerability of this regimen in these patients.

OUTLINE: Patients receive oral temozolomide once daily for 7 days every other week and oral thalidomide once daily. Treatment continues for up to 26 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 7.5-25 months.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Combination Therapy of a Protracted Oral Schedule of Temozolomide and Thalidomide as First-Line or Subsequent Therapy for Patients With Metastatic, Locally Advanced or Unresectable Leiomyosarcoma
Study Start Date : March 2002

Primary Outcome Measures :
  1. Response (complete and partial response)

Secondary Outcome Measures :
  1. Time to progression
  2. Overall survival
  3. Clinical benefit

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed leiomyosarcoma

    • Metastatic, locally advanced, or unresectable
  • Ineligible for other high priority national or institutional study
  • At least 1 unidimensionally measurable lesion documented on radiologic study

    • At least 2 cm by 2 cm
    • Not previously irradiated unless disease progression at the site is evident
  • No brain metastases



  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • More than 2 months


  • WBC greater than 3,000/mm^3
  • Neutrophil count at least 1,500/mm^3
  • Platelet count greater than 70,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin less than upper limit of normal (ULN)
  • SGOT or SGPT less than 1.5 times ULN*
  • Alkaline phosphatase less than 2 times ULN* NOTE: * Less than 5 times ULN if documented liver disease


  • Creatinine less than 1.5 times normal OR
  • Creatinine clearance greater than 60 mL/min
  • BUN less than 1.5 times normal


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study therapy
  • No acute infection requiring systemic antibiotics
  • No frequent vomiting or medical condition that would preclude intake of oral medication (e.g., partial bowel obstruction)
  • No other serious medical or psychiatric illness that would preclude study participation
  • No prior malignancy except curatively treated carcinoma in situ of the cervix or skin cancer


Biologic therapy:

  • Not specified


  • At least 4 weeks since prior chemotherapy
  • No more than 3 prior systemic chemotherapy regimens for metastatic, locally advanced, or unresectable leiomyosarcoma
  • Prior dacarbazine allowed

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to 50% or more of bone marrow
  • Concurrent radiotherapy for local control or palliative therapy for painful bony or soft tissue lesion allowed


  • At least 4 weeks since prior surgery and recovered


  • Recovered from all prior therapies
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033709

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center

Publications of Results:
Boyar M, Keohan ML, Hesdorffer M, et al.: Phase II study of temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma. [Abstract] J Clin Oncol 23 (Suppl 16): A-9029, 823s, 2005. Identifier: NCT00033709     History of Changes
Other Study ID Numbers: CDR0000069314
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: May 2005

Keywords provided by National Cancer Institute (NCI):
adult leiomyosarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
uterine leiomyosarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Muscle Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors