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:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT00022295
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed solid tumor
* Refractory to standard therapy OR
* No standard therapy exists
* No breast cancer
* No active CNS metastases
* Known CNS metastases must be previously treated with radiotherapy or surgery and stable for at least 4 weeks prior to study
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* Platelet count greater than 100,000/mm\^3
* WBC greater than 3,000/mm\^3
* Neutrophil count greater than 1,500/mm\^3
* Hemoglobin greater than 10 g/dL (9 g/dL for women)
Hepatic:
* Bilirubin less than 1.2 mg/dL
* Transaminases no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 1.4 mg/dL
Other:
* No active infection
* No contraindication to the insertion of a vascular access device
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent systemic anticancer immunotherapy
Chemotherapy:
* No concurrent systemic anticancer chemotherapy
Endocrine therapy:
* No concurrent systemic anticancer hormonal therapy except luteinizing hormone-releasing hormone agonists or antagonists
Radiotherapy:
* See Disease Characteristics
* Concurrent localized radiotherapy for control of local disease complications allowed
Surgery:
* See Disease Characteristics
Other:
* Recovered from prior antineoplastic therapy
* At least 4 weeks since prior investigational agents
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00022295
Study Brief:
Protocol Section:
NCT00022295