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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00645060
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed advanced solid tumor for which no standard or effective treatment is available
* Patients who refuse an available standard but non-curative treatment may also be eligible
* Tumors must produce CEA as documented by either an elevated serum CEA above the upper limit of normal (ULN) or by immunohistochemical (IHC) methods
* Positive CEA IHC stain is determined if more than 30% of the tumor cells have an intensity of 2+ or greater
* Measurable disease
* Estimated \< 1/3 of liver involvement if tumor involves the liver
* No brain or leptomeningeal involvement with cancer
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* WBC ≥ 4,000/μL
* ANC ≥ 1,500/μL
* Platelet count ≥ 125,000/μL
* Creatinine ≤ 1.5 mg/dL and/or creatinine clearance \> 60 mL/min
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 2 times ULN
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients currently being treated for severe infections or recovering from other intercurrent illnesses (such as poorly controlled diabetes or hypertension) are ineligible until recovery is deemed complete by the investigator
* Serum anti-antibody testing must be negative for human anti-humanized antibodies (if patient received prior monoclonal antibody)
* Serum HIV-negative
* Serum hepatitis B antigen- and hepatitis C antibody-negative
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior radiotherapy, immunotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
* Recovered from prior major surgery
* No prior radiotherapy to \> 50% of bone marrow
* No other concurrent chemotherapy, radiotherapy, or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00645060
Study Brief:
Protocol Section:
NCT00645060