NCT00033709

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2002

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 6, 2014

Status Verified

May 1, 2005

First QC Date

April 9, 2002

Last Update Submit

January 3, 2014

Conditions

Sarcoma

Keywords

adult leiomyosarcomastage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcomauterine leiomyosarcomastage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

  • Response (complete and partial response)

Secondary Outcomes (3)

  • Time to progression

  • Overall survival

  • Clinical benefit

Interventions

temozolomideDRUG
thalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 19043564RESULT

MeSH Terms

Conditions

SarcomaLeiomyosarcoma

Interventions

TemozolomideThalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Robert N. Taub, MD, PhD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2002

First Posted

January 27, 2003

Study Start

March 1, 2002

Last Updated

January 6, 2014

Record last verified: 2005-05

Locations

US(1)