At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 6 enrolled

Drug / intervention

Aldesleukin +2 morebiological

Likely dose

Aldesleukin 105 IUfrom 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/NCT00027807

NCT00027807Phase 1Completed

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Treatment of Stage IV Breast Cancer With OKT3 x Herceptin Armed Activated T Cells, Low Dose IL-2, And GM-CSF (Phase I Only as of 4-22-09 as Per IRB Approval Date)

Barbara Ann Karmanos Cancer Institute·interventional·Posted Jan 27, 2003·Updated Feb 17, 2016

In Brief

A Phase 1 clinical trial evaluating Aldesleukin, Sargramostim, and 1 other intervention for Breast Cancer. Completed, enrolled 6 participants across 1 site.

Detailed Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining different biological therapies in treating women who have stage IV breast cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2001

First PostedJan 2003

Primary CompletionSep 2010

Study CompletionMar 2013

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartOct 1, 2001

Primary CompletionSep 1, 2010

Study CompletionMar 1, 2013

TodayJul 2, 2026

Enrollment to primary: 8.9 yearsPosted 23.4 years ago

Interventions

Aldesleukinbiological

Subcutaneous injections of IL-2 (3.0 × 105 IU/m2/day) starting 3 days before the 1st armed ATC infusion and ending 7 days after the last armed ATC infusion.

Sargramostimbiological

GM-CSF Injections will be given SQ GM-CSF (250 μg/m2/twice weekly), to start 3 days before the first ATC infusion and ending 1 week after the last ATC infusion.

therapeutic autologous lymphocytesbiological

The time for armed-ATC infusions will vary from patient to patient, but the dose of armed-ATC (up to 40 billion) will be given over 30 min.