Advertisement

Topics

Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery

2014-07-23 21:08:44 | BioPortfolio

Summary

RATIONALE: Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy followed by laboratory-treated T cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II clinical trial is studying how well giving laboratory-treated T cells after chemotherapy works in treating women with stage II or stage III breast cancer undergoing surgery.

Description

OBJECTIVES:

- To determine, in a phase II clinical trial of women with stage II-III triple-negative breast cancer, if a regimen of neoadjuvant chemotherapy followed by HER2Bi-armed activated T cells (ATCs) improves the pathologic complete response (pCR) rate at the time of surgery.

- To investigate the association between pCR and clinical responses (disease-free survival and overall survival).

- To determine if HER2Bi-armed ATCs administered after neoadjuvant chemotherapy will modulate the cytotoxicity of lymphocytes in the blood and tumor-infiltrating lymphocytes.

- To determine if there is an association between systemic and tumor site anti-tumor responses.

- To determine if HER2Bi-armed ATCs administration after neoadjuvant chemotherapy decreases the frequency and colony-forming ability of the putative breast cancer stem cells in the tumor tissue at the time of surgery compared to that obtained in the tumor biopsy after chemotherapy.

- To investigate the association between the observed changes in numbers and proportion of CD44^hi/CD24^lo, CD133, aldehyde dehydrogenase activity (ALDH1)-positive cells and the pCR.

OUTLINE: This is a multicenter study.

- Neoadjuvant chemotherapy: Patients receive doxorubicin hydrochloride and cyclophosphamide every 2 weeks for 4 doses. Patients then receive paclitaxel once a week for 12 doses.

- Neoadjuvant immunotherapy: Beginning 3-6 days after the last dose of chemotherapy, patients receive autologous HER2Bi-armed activated T cells (ATCs) IV over 30-60 minutes once a week for 4 weeks.

- Surgery: Approximately 2 weeks after the last dose of HER2Bi-armed ATCs, patients undergo standard surgery.

Tissue and blood samples are collected periodically for correlative immune function tests.

After completion of study treatment, patients are followed up every 8 weeks for 48 weeks and then every 3 months thereafter.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

HER2Bi-armed activated T cells, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, laboratory biomarker analysis, neoadjuvant therapy, therapeutic conventional surgery

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:44-0400

Clinical Trials [4252 Associated Clinical Trials listed on BioPortfolio]

Pembrolizumab and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer

This phase II trial studies how well pembrolizumab and HER2Bi-armed activated T cells work in treating patients with castration resistant prostate cancer that has spread to other places in...

Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-neg...

Cyclophosphamide and Doxorubicin or Paclitaxel in Treating Women With Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combinin...

Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by st...

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer t...

PubMed Articles [17770 Associated PubMed Articles listed on BioPortfolio]

Partial Protection of Paclitaxel-induced Neurotoxicity by Antioxidants.

In order to search for substances that reduce the neurotoxicity of paclitaxel, the sensitivity of differentiated rat neuronal PC12 cells to paclitaxel was compared to that of malignant and non-maligna...

Triptolide sensitizes breast cancer cells to Doxorubicin through the DNA damage response inhibition.

Triptolide is an active component from a Chinese herb, Tripterygium wilfordii which has been applied for treating immune-related diseases over centuries. Recently, it was reported that a variety of ca...

Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil or Caelyx in advanced ovarian cancer.

To compare the pharmacokinetic bioequivalence and safety of a generic pegylated liposomal doxorubicin formulation (SPIL DXR hydrochloride liposome injection) with that of the reference products, Caely...

Isobavachalcone sensitizes cells to E2-induced paclitaxel resistance by down-regulating CD44 expression in ER+ breast cancer cells.

Oestrogen receptor (ER) is expressed in approximately 60%-70% of human breast cancer. Clinical trials and retrospective analyses have shown that ER-positive (ER+) tumours are more tolerant to chemothe...

Adjuvant dose-dense doxorubicin-cyclophosphamide versus docetaxel-doxorubicin-cyclophosphamide for high-risk breast cancer: First results of the randomised MATADOR trial (BOOG 2004-04).

Dose-dense administration of chemotherapy and the addition of taxanes to anthracycline-based adjuvant chemotherapy have improved breast cancer survival substantially. However, clinical trials directly...

Medical and Biotech [MESH] Definitions

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

Any differences arising between two nations or groups and leading to the intervention of armed forces.

Cytolytic lymphocytes with the unique capacity of killing natural killer (NK)-resistant fresh tumor cells. They are INTERLEUKIN-2-activated NK cells that have no MAJOR HISTOCOMPATIBILITY COMPLEX restriction or need for antigen stimulation. LAK cells are used for ADOPTIVE IMMUNOTHERAPY in cancer patients.

Members held prisoner of the armed forces, members of militias of such armed forces, members of other militias, members of other volunteer corps, and organized resistance movements. (Geneva Convention of 1929 and 1949)

More From BioPortfolio on "Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial