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A Multi-Center Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide With Autologous Progenitor Cell Transplantation for the Treatment of Inflammatory Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Breast Neoplasm, Neoplasm Metastasis

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Trial Information

A Multi-Center Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide With Autologous Progenitor Cell Transplantation for the Treatment of Inflammatory Breast Cancer


Efforts to cure high-risk breast cancer have increasingly focused on the application of dose
intensive chemotherapy. To date, the use of dose intensive and high-dose chemotherapy has
not significantly changed the survival for the majority of high risk and metastatic
patients. The optimal schedule and combination of agents to improve the results of
high-dose chemotherapy is not known. This study will pilot a combination of chemotherapy
agents for the treatment of Inflammatory Breast Cancer.


To define, in a statistically relevant manner, the clinical efficacy of this chemotherapy
regimen combination in the treatment of Inflammatory Breast Cancer (stage IIIB

To examine the effects of this high-dose chemotherapy on T-cells (T-cell number, phenotype,
cytokine profiles) and study the process of post-chemotherapy T-cell regeneration.


Newly diagnosed patient with non metastatic Inflammatory Breast Cancer (stage III B).

The patients treated in this study will also be eligible for entrance into other protocols
of the experimental Transplantation & Immunology Branch that are examining strategies of
manipulating T-cell regeneration in adults after intensive chemotherapy.


Patients will receive multiple cycles of a dose intensive combination of Paclitaxel and
Cyclophosphamide both for the mobilization of peripheral blood progenitor cells and with
therapeutic intent. A second induction regimen will consist of four cycles of the
combination of Doxorubicin / cyclophosphamide. Patients will subsequently receive high-dose
Melphalan and Etoposide followed by the infusion of peripheral blood progenitor cells and
granulocytes colony-stimulating-factor (G-CSF).

Inclusion Criteria



Age greater or equal to 18 years.

All patients must have a histologically confirmed diagnosis of Inflammatory Breast
Carcinoma stage III B. Patients with no clinical inflammatory signs but with tumor
invasion of dermal lymphatic on histology are eligible. Patients with metastatic disease
and Inflammatory Breast Carcinoma are not eligible. All pathologic material must be
reviewed and confirmed by the Department of Pathology of the treating institution prior to
treatment (there will be no central pathology review).

Patients may be untreated or may have received prior induction chemotherapy outside the
NCI. If patients received prior induction chemotherapy, they may not have been
unresponsive to it. They may have received chemotherapy either before (neo-adjuvant
setting) or after local surgery (adjuvant setting).

Karnofsky performance status of greater than 70% (ECOG 0 or 1).

Ejection fraction by MUGA or 2-D echocardiogram within institution normal limits.

Creatinine clearance of greater than 60 cc/mm.

AST and ALT less than 3 times the upper limit of normal.

Bilirubin less than 1.5 (except in cases of Gilbert's disease).

ANC greater than l000/mm(3).

Platelet count greater than 90,000/mm(3).

DLCO greater than 50%.

No history of medical or psychiatric disease which would preclude safe treatment in the
view of the principal investigator.

No history of abnormal bleeding tendency or predisposition to repeated infections.

Patients must be able to give informed consent.


Patients with Inflammatory Breast Cancer but with metastatic disease.

Any patient may be excluded from this study at the discretion of the principal
investigator if it is deemed that allowing participation would represent an unacceptable
medical or psychiatric risk.

Any patient with a need for chronic steroids or anticoagulation will be ineligible.

Any patient testing positive for HIV (AIDS) or hepatitis B or C will be ineligible.

Any female patient known or found to be pregnant will be considered ineligible. Patients
of childbearing potential unwilling to practice contraception will be ineligible.

Any patient with an active second malignancy (excluding treated skin cancers or carcinoma
in situ) will be ineligible.

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald E Gress, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

July 1996

Completion Date:

Related Keywords:

  • Breast Neoplasm
  • Neoplasm Metastasis
  • T-Cells
  • CD34+ Selection
  • T-Cell Depletion
  • Apheresis
  • Mobilization
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Inflammatory Breast Neoplasms



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