Clinical trial · Interventional
Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response (complete and partial response)
Secondary outcomes (3)
- measure
- Time to progression
- measure
- Overall survival
- measure
- Clinical benefit
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * More than 2 months Hematopoietic: * 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 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 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
References
Publications (1)
- RESULTBoyar MS, Hesdorffer M, Keohan ML, Jin Z, Taub RN. Phase II Study of Temozolomide and Thalidomide in Patients with Unresectable or Metastatic Leiomyosarcoma. Sarcoma. 2008;2008:412503. doi: 10.1155/2008/412503. Epub 2008 Nov 16. PMID 19043564