Vaccine Therapy in Treating Patients With Advanced Kidney Cancer

Completed · Phase 1

Conditions studied: Kidney Cancer

In brief

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced kidney cancer.

Key facts

Study ID

NCT00004880

Run by

Jonsson Comprehensive Cancer Center

People needed

14

Starts

1997-06-01

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed metastatic renal cell carcinoma Evaluable or bidimensionally measurable disease with primary renal tumor in place or surgically accessible metastatic site greater than 2 x 2 cm
• Over 18
• ECOG 0-1
• Hematopoietic:
• Hemoglobin at least 10 g/dL (not transfusion dependent)
• Platelet count at least 75,000/mm3
• WBC greater than 3,000/mm3
• Hepatic: SGOT/SGPT no greater than 5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 5 times ULN
• PT/PTT no greater than 1.5 times ULN
• Bilirubin no greater than 2.5 mg/dL
• Renal: Creatinine no greater than 2.0 g/dL
• Hepatitis B surface antigen negative
• Negative pregnancy test
• Fertile patients must use effective contraception
• At least 4 weeks since prior immunotherapy
• At least 4 weeks since prior chemotherapy
• At least 4 weeks since prior radiotherapy
• At least 14 days since prior acute therapy for infection

You may not qualify if…

• uncontrolled CNS metastasis
• ischemic heart disease that precludes surgery
• pulmonary condition that precludes surgery
• other underlying condition or allergy that would preclude study
• acute viral, bacterial, or fungal infection requiring therapy HIV negative
• pregnant or nursing
• other acute medical problems that would preclude study
• concurrent corticosteroids (oral, topical, inhaled)
• prior organ allografts

Where it is running

• Jonsson Comprehensive Cancer Center, UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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