DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC

Completed · Phase 2

Conditions studied: Kidney Cancer

In brief

RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Interferon alfa may interfere with the growth of cancer cells. Combining vaccine therapy with interleukin-2 and interferon alfa may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with interleukin-2 and interferon alfa works in treating patients with metastatic renal cell carcinoma (kidney cancer).

Key facts

Study ID: NCT00085436
Run by: Dartmouth-Hitchcock Medical Center
People needed: 18
Starts: 2003-12-01
Expected to finish: 2009-10-01
Last updated by the study team: 2018-06-26

Who can join

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

You may qualify if…

Histologically confirmed metastatic renal cell carcinoma with measurable disease.
Tumor tissue available and properly stored for lysate preparation.
Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects.
Karnofsky Performance Status ≥60%
Life expectancy ≥ twelve weeks
Adequate end organ function:
Hematological: ANC ≥ 1000cells/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8.5 g/dl
Liver: AST < 2 x ULN (upper limit of normal) unless due to metastases then < 5 x ULN, serum total bilirubin < 2 x ULN (except for patients with Gilbert's Syndrome)
Renal: serum creatinine < 2.0 x ULN.
Pulmonary: FEV1 > 2.0 liters or > 75% of predicted for height and age.
Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, or serious cardiac arrhythmias. Patients over 40 or have had previous myocardial infarction greater than 6 months prior to entry will be required to have a negative or low probability cardiac stress test for cardiac ischemia.
CNS: No history of brain metastases.
Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
Appropriate Contraception in both sexes

You may not qualify if…

Patients may have not have been treated previously with IL-2, IFNα or autologous vaccine.
Concomitant second malignancy except for non-melanoma skin cancer, and non- invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
In patients with a prior history of invasive malignancy, less than five years in complete remission
Positive serology for HIV, hepatitis B or hepatitis C,
Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen.
Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at least 4 weeks must have passed since the last dose).
History of autoimmune disease.

Where it is running

Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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