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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00301730 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastatic Cancer |
Biological: aldesleukin Biological: therapeutic tumor infiltrating lymphocytes Biological: trastuzumab Drug: paclitaxel Procedure: conventional surgery |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Adoptive Immunotherapy With Costimulated Tumor-Derived T Cells After Allogeneic Hematopoietic Stem Cell Transplantation |
| Estimated Enrollment: | 1 |
| Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy
Operable tumor with at least 1 cm of surgically accessible lesion
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Principal Investigator: | Michael R. Bishop, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000455626, NCI-05-C-9980, NCI-SE-05-03 |
| Study First Received: | March 9, 2006 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00301730 History of Changes |
| Health Authority: | United States: Federal Government |
|
lung metastases stage IV breast cancer recurrent breast cancer |
|
Anti-HIV Agents Skin Diseases Breast Neoplasms Antimitotic Agents Antiviral Agents Recurrence Aldesleukin |
Anti-Retroviral Agents Paclitaxel Tubulin Modulators Neoplasm Metastasis Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |
|
Anti-Infective Agents Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplastic Processes |
Neoplasms by Site Pathologic Processes Aldesleukin Anti-Retroviral Agents Paclitaxel Therapeutic Uses Tubulin Modulators Neoplasm Metastasis Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |
