Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT00053794
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic or locally advanced soft tissue sarcoma that is incurable by standard therapies, including any of the following types:
* Uterine sarcomas
* Mixed mesodermal
* Leiomyosarcoma
* Endometrial stromal sarcoma
* Alveolar soft part sarcoma
* Angiosarcoma/lymphangiosarcoma
* Fibrosarcoma
* Hemangiopericytoma
* Leiomyosarcoma
* Liposarcoma
* Malignant fibrous histiocytoma
* Neurogenic sarcoma
* Pleomorphic rhabdomyosarcoma
* Synovial sarcoma
* Unclassifiable sarcoma
* Undifferentiated sarcoma
* Excluded diseases include the following:
* Bone sarcomas (e.g., osteosarcoma, Ewing's sarcoma, chondrosarcoma)
* Embryonal rhabdomyosarcoma
* Carcinosarcoma
* Kaposi's sarcoma
* Malignant mesothelioma
* Neuroblastoma
* Gastrointestinal stromal tumor
* At least 1 unidimensionally measurable site of disease (outside the previously irradiated area) defined as:
* At least 20 mm by x-ray or physical exam
* At least 10 mm by spiral CT scan
* At least 20 mm by non-spiral CT scan NOTE: Bone lesions are not considered measurable
NOTE: Patients whose sole site of disease is within a previously irradiated area are allowed if there is evidence of progression or new lesions in the irradiated field
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
Renal
* Creatinine no greater than ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* No active or ongoing infection
* No psychiatric illness or social situation that would limit compliance with study requirements
* No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior systemic chemotherapy for metastatic or locally advanced disease
* At least 6 months since prior adjuvant chemotherapy
* No other concurrent cytotoxic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy)
* No concurrent radiotherapy to the sole site of measurable disease or for progressively symptomatic disease
Surgery
* At least 4 weeks since prior major surgery
Other
* No other concurrent anticancer therapy or investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00053794
Study Brief:
Protocol Section:
NCT00053794