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Clinical Trials/NCT00085436
NCT00085436CompletedPhase 2

A Phase II Study Of Autologous Tumor/DC Vaccine (DC Vaccine) Combined With Interleukin-2 (IL-2) And Interferon-α-2a (IFNα-2a) In Patients With Metastatic Renal Cell Carcinoma (RCC)

Dartmouth-Hitchcock Medical Center2 sites in 1 country18 target enrollmentStarted: December 2003Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Clinical Response as Measured by RECIST

Study Overview

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 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).

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 vaccine) in combination with interleukin-2 and interferon-alfa.
  • Determine the toxicity of this regimen in these patients.

Secondary

  • Determine, within relevant immune pathways, the treatment-related, tumor-specific immune response in patients treated with this regimen.
  • Correlate tumor-specific immune response with objective clinical response in patients treated with this regimen.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 Criteria

  • Not provided

Arms & Interventions

Vaccine, Aldesleukin-2, Interferon-a

Experimental

All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.

Intervention: Aldesleukin, (Biological)

Vaccine, Aldesleukin-2, Interferon-a

Experimental

All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.

Intervention: autologous tumor cell vaccine (Biological)

Vaccine, Aldesleukin-2, Interferon-a

Experimental

All patients will be treated with autologous tumor cell vaccine administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and recombinant interferon alfa. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.

Intervention: recombinant interferon alfa (Biological)

Outcomes

Primary Outcomes

Clinical Response as Measured by RECIST

Time Frame: monthly, then every 2-3 months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcomes

  • Immunity as Measured by T-cell and Antibody Responses to the Tumor(monthly for 5 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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