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.
Primary Purpose: Treatment
Michael R. Bishop, MD
National Cancer Institute (NCI)
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|