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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00228358

NCT00228358
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have breast cancer, ovarian cancer, or non-small cell lung cancer that has spread to other parts of the body, is getting worse, and cannot be cured with standard treatments (including the drug trastuzumab)
  • Your cancer has a specific protein on its surface called HER2/neu, which was confirmed by testing of your tumor (either the original tumor or a spread)
  • Your cancer can be measured or tracked — either through scans (such as CT, PET, or MRI) showing tumors of a certain size, through bone scans, or (for ovarian cancer) through a blood marker called CA-125
  • You have previously received HER2-targeted vaccines as part of an approved vaccine study at the University of Washington
  • After your vaccination, you had a blood cell collection procedure (called leukapheresis) through an approved University of Washington study, and those collected cells have been stored for future use
  • You are generally well enough to carry out daily activities with little or no limitation (confirmed by a standard health performance score)
  • You may currently be receiving trastuzumab, lapatinib, hormone therapy, or bone-strengthening medication (bisphosphonates)
  • If you are on trastuzumab or lapatinib, your heart function has been checked by a scan within the past 90 days and is adequate
  • You have been off all immune-suppressing treatments and steroid medicines for at least 14 days before starting the study
  • You have been off chemotherapy and trastuzumab for at least one week before your first treatment in this study
  • If you are able to have children, you agree to use contraception throughout the study and for one month after your last treatment
  • If you have had cancer spread to the brain in the past, a recent brain scan (within 30 days) shows it is stable
  • Your blood counts and organ function meet certain minimum levels, including healthy enough white blood cells, red blood cells, and platelets, as well as kidneys and liver working within acceptable ranges (confirm specific numbers with trial site)

Who may not be able to join:

  • You are currently enrolled in another treatment research study
  • You have certain heart problems, such as a specific type of heart muscle disease (restrictive cardiomyopathy) causing symptoms, chest pain (unstable angina) within the past 4 months, or significant heart failure that is being actively treated
  • You have an autoimmune disease (where your immune system attacks your own body) that is not well controlled with treatment
  • You are pregnant or currently breastfeeding
  • You have a known allergy or serious reaction to diphtheria toxin or a substance called interleukin-2 (IL-2) — this applies only to people joining a specific group within the trial (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
University of Washington
Registry
clinicaltrials_gov
Start date
1 June 2003
Est. completion
1 May 2011

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Feasibility of expanding HER2 specific T cells ex vivo to achieve a target T cell expansion of 1x10^10 HER2 specific T cells; Safety of infusing HER2 specific T cells

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov