Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	CPMC-IRB-14323 NCI-G02-2060, NCT00033709

Objectives

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• 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

Radiotherapy:

• 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

Surgery:

• At least 4 weeks since prior surgery and recovered

Other:

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• More than 2 months

Hematopoietic:

• WBC greater than 3,000/mm³
• Neutrophil count at least 1,500/mm³
• Platelet count greater than 70,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• 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]

Renal:

• Creatinine less than 1.5 times normal

  OR

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

Other:

• 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

Expected Enrollment

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

Outcomes

Response (complete and partial response)

Time to progression
Overall survival
Clinical benefit

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.

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Robert Taub, MD, PhD, Protocol chair		Ph: 212-305-4076

Registry Information
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
Trial Start Date		2002-03-01
Registered in ClinicalTrials.gov		NCT00033709
Date Submitted to PDQ		2002-03-01
Information Last Verified		2005-05-10
NCI Grant/Contract Number		P30-CA13696

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