CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
aldesleukin +1 morebiological
Likely dose
allogeneic large multivalent immunogen vaccine 0.2 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00726739
NCT00726739Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen (LMI) Vaccine for the Treatment of Stage IV Melanoma

Masonic Cancer Center, University of Minnesota·interventional·Posted Aug 1, 2008·Updated Dec 28, 2017

In Brief

A Phase 2 clinical trial evaluating aldesleukin and allogeneic large multivalent immunogen vaccine for Stage IV Melanoma. Completed, enrolled 21 participants across 1 site.

Detailed Summary

RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma. PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with stage IV melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage IV Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2008
Enrollment StartJun 1, 2008
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.9 years ago

Interventions

aldesleukinbiological

IL-2 Alone - administer 10 x 10\^6 International Units subcutaneously (SQ) will be given on day 1 and day 2 every 4 weeks until disease progression or for a maximum of 12 treatment cycles.

allogeneic large multivalent immunogen vaccinebiological

Allogeneic tumor cell membrane-coated large multivalent immunogen (LMI \[1 x 10\^7, 5-μm silica spheres\]) will be given as an intradermal injection every 4 weeks for up to 12 injections. Each vaccine dose will be 0.2 ml.