Biological Therapy and Chemotherapy in Treating Patients With Metastatic Kidney Cancer or Colorectal Cancer

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of biological therapy combined with chemotherapy in treating patients who have metastatic kidney cancer or colorectal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Luke's Medical Center
• Treatments: Fluorouracil; Interferon-alpha; Interferons; Sargramostim

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