Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer
Colorectal Cancer, Kidney Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer, stage IV renal cell cancer, recurrent renal cell cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic renal cell carcinoma or colorectal carcinoma, meeting 1 of the following criteria: Obtained no benefit from prior standard or salvage therapy Ineligible for standard therapy because of concurrent illness Declined standard therapy At least 1 site of measurable disease that can be measured in at least 1 dimension At least 20 mm with conventional techniques OR at least 10 mm with spiral CT scan No untreated or unstable, treated brain metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 4,000/mm^3 Granulocyte count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL No coagulation disorders Hepatic: Bilirubin no greater than 2.5 mg/dL* ALT/AST less than 3 times upper limit of normal* PT no greater than 1.5 times control (unless therapeutically anticoagulated) PTT less than 1.5 times control (unless therapeutically anticoagulated) NOTE: *Patients whose cancer has led to values that do not fall within the above ranges may be eligible at the discretion of the investigators Renal: Creatinine no greater than 2.0 mg/dL* NOTE: *Patients whose cancer has led to values that do not fall within the above range may be eligible at the discretion of the investigators Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No thrombophlebitis Pulmonary: FEV_1 and FVC at least 65% predicted No uncontrolled pulmonary embolism Other: No other malignancy within the past 5 years except resected basal cell skin cancer or carcinoma in situ of the cervix No prior allergic reactions attributed to compounds of similar chemical or biologic composition to interleukin-12-primed activated T cells or other study agents No active autoimmune disease No uncontrolled thyroid abnormalities No ongoing or active infection No other uncontrolled concurrent illness No psychiatric illness or social situations that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for up to 2 years after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since prior immunotherapy Chemotherapy: More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: At least 4 weeks since prior steroid therapy or steroid-containing compounds At least 2 weeks since prior topical or inhaled steroids Radiotherapy: More than 4 weeks since prior radiotherapy and recovered Surgery: More than 4 weeks since prior major surgery Other: No other concurrent investigational agents No other concurrent commercial anticancer agents No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center