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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT00064220
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma of 1 of the following tumor types:
* Malignant fibrous histiocytoma
* Liposarcoma
* Rhabdomyosarcoma
* Synovial sarcoma
* Malignant paraganglioma
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma, including hemangiopericytoma
* Malignant peripheral nerve sheath tumor
* Unclassified sarcoma
* Miscellaneous sarcoma, including mixed mesodermal tumors of the uterus
* The following tumor types are not eligible:
* Gastrointestinal stromal tumor
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma
* Embryonal rhabdomyosarcoma
* Evidence of disease progression
* Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease
* Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy
* At least 1 measurable lesion with indicator lesions outside of any prior radiation field
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
* 15 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
* Bilirubin no greater than 1.5 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* Ejection fraction at least 40% by MUGA
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No baseline neurotoxicity grade 2 or greater
* No concurrent serious infection
* No psychiatric disorder that would preclude giving informed consent or complying with study requirements
* No other concurrent severe or uncontrolled medical illness that would preclude study participation
* No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent anticancer biologic therapy
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy and recovered
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No concurrent radiotherapy
* Localized radiotherapy to a non-indicator lesion for pain relief allowed provided all other methods of pain control are ineffective
Surgery
* At least 4 weeks since prior major surgery and recovered
Other
* At least 4 weeks since prior myelosuppressive therapy
* At least 4 weeks since prior investigational drugs
* No other concurrent investigational drugs
* No other concurrent anticancer cytotoxic therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00064220
Study Brief:
Protocol Section:
NCT00064220