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Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation

Phase 1
18 Years
75 Years
Not Enrolling
Breast Cancer, Metastatic Cancer

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Trial Information

Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation



- 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.

Inclusion Criteria


- 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

- No concurrent immunosuppressive therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael R. Bishop, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • lung metastases
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182