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Paclitaxel/Cyclophosphamide and High-Dose Melphalan/Etoposide Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IIIB Inflammatory Breast Cancer

2014-08-27 03:56:48 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, melphalan, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cells are killed.

PURPOSE: This phase I/II trial is studying the side effects of giving paclitaxel, cyclophosphamide, melphalan, and etoposide together with peripheral stem cell transplant and to see how well it works in treating patients with stage IIIB inflammatory breast cancer.

Description

OBJECTIVES:

- Determine the clinical efficacy of paclitaxel and cyclophosphamide followed by high-dose melphalan and high-dose etoposide with autologous peripheral blood stem cell rescue in patients with stage IIIB inflammatory breast cancer.

- Determine the effect of this regimen on T cells, in terms of number, phenotype, and cytokine profiles, in these patients.

- Determine the process of postchemotherapy T-cell regeneration in patients treated with this regimen.

- Determine the status of a number of key signal transduction pathways that may contribute to the inflammatory breast cancer phenotype.

OUTLINE:

- Induction chemotherapy: Patients receive induction chemotherapy comprising paclitaxel IV over 24 hours and cyclophosphamide IV over 1 hour on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once or twice daily beginning on day 5 and continuing until apheresis is completed. Treatment repeats every 29 days for up to 3-9 courses. Patients may receive up to 2 additional courses after their best response.

At the discretion of the investigator, patients may also receive up to 4 additional courses of doxorubicin IV and cyclophosphamide IV over 1 hour on day 1 every 21 days to complete induction therapy.

- Apheresis: Peripheral blood stem cells are harvested after the second course (and third course if necessary) of induction chemotherapy to collect adequate CD34+ numbers.

- Transplantation: Beginning at least 21 days after completion of induction chemotherapy, patients receive high-dose melphalan IV over 30 minutes and high-dose etoposide IV over 8 hours on days 1-3. Autologous peripheral blood stem cells are reinfused on day 7. Patients receive G-CSF SC once daily beginning on day 7.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A maximum of 120 patients will be accrued for this study within 3.5 years.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

filgrastim, cyclophosphamide, doxorubicin hydrochloride, etoposide, melphalan, paclitaxel, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation

Location

NCI - Center for Cancer Research
Bethesda
Maryland
United States
20892

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:48-0400

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Medical and Biotech [MESH] Definitions

An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

A mixture of six synthetic oligopeptides, each containing MELPHALAN. It is used as a broad-spectrum antineoplastic due to its alkylating and antimetabolic actions but, is toxic to bone marrow, gastrointestinal system and vasculature.

An injectable formulation of albumin-bound paclitaxel NANOPARTICLES.

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.

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