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

Primary Purpose

Sarcoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
thalidomide
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Response (complete and partial response)

Secondary Outcome Measures

Time to progression
Overall survival
Clinical benefit

Full Information

First Posted
April 9, 2002
Last Updated
January 3, 2014
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033709
Brief Title
Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Response (complete and partial response)
Secondary Outcome Measure Information:
Title
Time to progression
Title
Overall survival
Title
Clinical benefit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert N. Taub, MD, PhD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19043564
Citation
Boyar 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.
Results Reference
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Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma

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