Cellular Adoptive Immunotherapy in Treating a Patient Who Has Undergone a Donor Stem Cell Transplant for Breast Cancer That Has Spread to the Lung

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301730
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : April 28, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing.

PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic Cancer Biological: aldesleukin Biological: therapeutic tumor infiltrating lymphocytes Biological: trastuzumab Drug: paclitaxel Procedure: conventional surgery Phase 1

Detailed Description:



  • Determine the antitumor response in a patient with persistent metastatic breast cancer after prior allogeneic hematopoietic stem cell transplantation (SCT) treated with tumor-derived, ex vivo expanded and costimulated T-lymphocytes.


  • Evaluate the immune function of tumor-derived T-lymphocytes and the biology of residual tumor cells present after allogeneic hematopoietic SCT.

OUTLINE: This is a pilot study.

The patient undergoes surgical resection of the accessible lesions from which T cells are isolated, costimulated, and expanded ex vivo to produce the tumor-derived T-lymphocytes (TDTL). Beginning at least 2 weeks after surgery, the patient receives TDTL IV every 4 weeks for up to 5 doses in the presence of disease progression (DP) AND in the absence of ≥ grade 2 graft-versus-host disease. The patient is assessed 4 weeks after every dose.

In case of stable disease, partial response, or complete response, the patient is followed without intervention until DP.

In case of DP after dose 1 or 2 of the TDTL, the patient receives dose 2 or 3 of the TDTL. In case of DP after dose 3 of the TDTL, the patient receives low-dose interleukin-2 subcutaneously (SC) daily for 3 days and dose 4 of the TDTL. In case of DP after dose 4 of the TDTL, the patient receives 1 course of chemoimmunotherapy for cytoreduction and immunomodulation comprising paclitaxel IV over 3 hours once and trastuzumab (Herceptin®) IV over 30-90 minutes once weekly for 3 weeks (the patient may receive gemcitabine hydrochloride, vinorelbine ditartrate, docetaxel, or capecitabine in combination with trastuzumab [Herceptin®] as chemoimmunotherapy at the discretion of the principal investigator); interleukin-2 SC daily for 3 days; and dose 5 of the TDTL. In case of DP after dose 5 of the TDTL, the patient may receive cytotoxic chemotherapy and/or FDA-approved biologic therapy and/or immunotherapy with donor lymphocyte infusions from the same donor used for the prior allogeneic stem cell transplantation.

The patient may undergo core biopsy of the left mediastinal nodule in case of tumor regression of the indexing lesion at anytime OR after receiving dose 5 of the TDTL.

After completion of study treatment, the patient is followed periodically for 5 years.

PROJECTED ACCRUAL: One patient will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Primary Purpose: Treatment
Official Title: Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago
  • Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6 HLA-matched sibling donor for refractory metastatic breast cancer
  • Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy

    • Pulmonary metastases progressed after prior allogeneic SCT
    • Responded in an objective and measurable manner to prior allogeneic lymphocyte infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®)
  • Disease limited to the thoracic cavity
  • Operable tumor with at least 1 cm of surgically accessible lesion

    • Preoperative risk assessment indicating ≤ 5% risk of mortality and < 15% risk of significant morbidity for pulmonary metastasectomy
  • Enrolled on protocol CC# 00-C-0119
  • Hormone receptor status not specified


  • Female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • Life expectancy > 6 months
  • Negative pregnancy test
  • Adequate pulmonary reserve
  • Prior graft-versus-host disease (GVHD) ≤ grade 1
  • No concurrent GVHD
  • No active infection nonresponsive to antimicrobial therapy
  • No active psychiatric disorder that would preclude study compliance


  • See Disease Characteristics
  • At least 4 weeks since prior systemic immunosuppressive therapy
  • At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab [Herceptin®])
  • No concurrent immunosuppressive therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301730

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Michael R. Bishop, MD National Cancer Institute (NCI) Identifier: NCT00301730     History of Changes
Other Study ID Numbers: CDR0000455626
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2006

Keywords provided by National Cancer Institute (NCI):
lung metastases
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents