Status:
COMPLETED
DC Vaccine Combined With IL-2 and IFNα-2a in Treating Patients With mRCC
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 kid...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response rate in patients with metastatic renal cell carcinoma treated with autologous dendritic cells (DC) loaded with autologous tumor lysate (DC vacci...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00085436
Start Date
December 1 2003
End Date
October 1 2009
Last Update
June 26 2018
Active Locations (1)
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1
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002