CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Aldesleukin, +2 morebiological
Likely dose
Autologous dendritic cell vaccine (1 × 10^7 DC cells injected into inguinal lymph node under ultrasound guidance), combined with aldesleukin (recombinant IL-2) 18 × 10^6 IU/m² per day as continuous 5-day IV infusion (Negrier regimen) and recombinant interferon-α-2a 6 million IU subcutaneously three times per weekAI-extracted
Key inclusion· 8
  • ✓Histologically confirmed metastatic renal cell carcinoma with measurable disease
  • ✓Tumor tissue must be available and properly stored for vaccine lysate preparation
  • ✓At least 4 weeks from last immunotherapy, radiation, surgery, or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects
  • ✓Karnofsky Performance Status ≥60%
Key exclusion· 7
  • ✕Prior treatment with IL-2, interferon-α, or autologous vaccine
  • ✕History of brain metastases
  • ✕Positive serology for HIV, hepatitis B, or hepatitis C
  • ✕History of autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00085436
NCT00085436Phase 2Completed
CompareCT.gov

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 Center·interventional·Posted Jun 11, 2004·Updated Jun 26, 2018

In Brief

A Phase 2 clinical trial evaluating Aldesleukin,, autologous tumor cell vaccine, and 1 other intervention for Kidney Cancer. Completed, enrolled 18 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartDec 1, 2003
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 22.1 years ago

Interventions

Aldesleukin,biological

Recombinant human interleukin-2 (Proleukin, Chiron Therapeutics) will be administered as a five day (120 hr) continuous intravenous infusion at a dose of 18x106 IU per square meter of body surface area per day as per the Negrier regimen (21). The treatment schedule consists of two induction cycles and three maintenance cycles. Each induction cycle consists of two five-day courses of interleukin-2 infusion separated by a nine-day break. Each maintenance cycle consists of a five-day infusion followed by 23-day rest period of no therapy.

autologous tumor cell vaccinebiological

we will administer 1 X 107 DC cells. The autologous tumor cell vaccine (1 X 107 cells/1cc) in lactated ringers solution and injected into one (or two if clinically necessary) inguinal lymph nodes under ultrasound guidance. Each cycle of DC vaccine will be administered alternately in the right and left inguinal lymph nodes.

recombinant interferon alfabiological

Recombinant human interferon alfa-2a (Roferon, Roche), at a dose of 6 million IU per day three times a week subcutaneously will be given during the two interleukin-2 induction cycles and during each interleukin-2 maintenance cycle