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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: April 9, 2002
Last updated: January 3, 2014
Last verified: May 2005

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 Intervention Phase
Drug: temozolomide
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical benefit [ Designated as safety issue: No ]

Study Start Date: March 2002
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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.

ClinicalTrials.gov Identifier: NCT00033709     History of Changes
Other Study ID Numbers: CDR0000069314  CPMC-IRB-14323  NCI-G02-2060 
Study First Received: April 9, 2002
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 30, 2016