CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Aldesleukin +2 morebiological
Likely dose
Bevacizumab given IV, followed by aldesleukin (interleukin-2) given subcutaneouslyAI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed metastatic renal cell cancer with >75% clear cell histology
  • At least one unidimensionally measurable lesion ≥20 mm by conventional imaging or ≥10 mm by spiral CT
  • Nominally 'good' or 'intermediate' risk disease meeting ≥4 out of 5 prognostic criteria (hemoglobin >10 g/dL, ECOG 0-1, normal calcium, primary tumor treated, LDH <1.5×ULN)
  • No prior refractory disease (defined as progression during or within 3 months after IL-2)
Key exclusion· 8
  • Prior bevacizumab therapy
  • History of allergic reaction to antibody drugs or IL-2
  • Insulin-dependent diabetes
  • Known HIV positivity

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

Search/NCT00126490
NCT00126490Phase 2Completed

Phase 2 Trial of Sequential Bevacizumab Then Subcutaneous Interleukin-2 in Metastatic Renal Cancer

National Cancer Institute (NCI)·interventional·Posted Aug 4, 2005·Updated Jun 30, 2015

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Bevacizumab, and 1 other intervention for Recurrent Renal Cell Carcinoma and Stage IV Renal Cell Cancer. Completed, enrolled 19 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving bevacizumab together with interleukin-2 works in treating patients with metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells to kill tumor cells. Giving bevacizumab together with interleukin-2 may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 4, 2005
Enrollment StartMar 1, 2005
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.9 years ago

Interventions

Aldesleukinbiological

Given subcutaneously

Bevacizumabbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies