Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer

NCT00001507 | Completed Phase 1

• 2 other identifiers: 96010496-C-0104
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of combination chemotherapy with paclitaxel (Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for treating inflammatory breast cancer. Patients also receive infusions of their own previously collected progenitor cells (primitive cells that can make new cells to replace ones destroyed by chemotherapy). Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not metastasized (spread beyond the breast) may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, and chest x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation. Participants undergo the following tests and procedures:

• Central venous line placement: Patients have a central venous line (plastic tube) placed into a major vein in the chest before beginning treatment. The line remains in the body throughout treatment and is used to give chemotherapy and other medications and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room.
• Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide. Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28 days apart. A drug called Mesna is given with this treatment to protect the bladder from irritation from cyclophosphamide. Patients who have not previously been treated with doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart. When all the paclitaxel/cyclophosphamide cycles are completed, patients receive melphalan and etoposide, both drugs I.V. over 1 to 8 hours for three consecutive days.
• G-CSF treatment: After each paclitaxel/cyclophosphamide cycle and after the melphalan/etoposide treatment, patients are given a drug called G-CSF. G-CSF, injected under the skin, stimulates production of infection-fighting white blood cells.
• Apheresis: This is a procedure to collect progenitor cells for later reinfusion. For this procedure, blood is collected through a catheter (plastic tube) placed in an arm vein. The blood is circulated through a cell-separating machine, where the white cells, including the progenitor cells, are extracted, and the red cells are returned to the patient through another catheter in the other arm. Apheresis is done after each of two cycles of paclitaxel/cyclophosphamide.
• Progenitor cell transplant: Progenitor cells are reinfused after melphalan/etoposide treatment.
• Glucose infusion: A salt solution with chemically modified glucose is infused I.V. over a period of from 12 to 48 hours, with subsequent donation of blood cells for blood and immune system studies. Patients have a maximum of two glucose infusions, separated by at least 3 months.
• Tumor biopsy: Some patients have a biopsy of their tumor (removal of a small piece of tumor tissue for microscopic study) before starting chemotherapy.
• Blood tests: Blood is drawn frequently to monitor safety and treatment response, and for research purposes.
• Dental consultation: Some patients may have a dental consultation before the progenitor cell transplant.

Conditions

Breast Neoplasm; Neoplasm Metastasis

Keywords

T-cells; CD34+ Selection; T-Cell Depletion; Apheresis; Mobilization

Interventions

Monoclonal Antibody 3A1 DRUG

Monoclonal Antibody 95-5-49 DRUG

Monoclonal Antibody 95-6-22 DRUG

Baxter Isolex 3001 Stem Cell Selection System DEVICE

Ceprate SC DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Shpall EJ, Jones RB, Bearman S. High-dose therapy with autologous bone marrow transplantation for the treatment of solid tumors. Curr Opin Oncol. 1994 Mar;6(2):135-8. doi: 10.1097/00001622-199403000-00004.

  PMID: 8011690 BACKGROUND

• Peters WP, Ross M, Vredenburgh JJ, Meisenberg B, Marks LB, Winer E, Kurtzberg J, Bast RC Jr, Jones R, Shpall E, et al. High-dose chemotherapy and autologous bone marrow support as consolidation after standard-dose adjuvant therapy for high-risk primary breast cancer. J Clin Oncol. 1993 Jun;11(6):1132-43. doi: 10.1200/JCO.1993.11.6.1132.

  PMID: 8501500 BACKGROUND

• Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.

  PMID: 7919339 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald E Gress, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: July 12, 1996
• Primary Completion: June 30, 1998
• Study Completion: June 20, 2014
• Last Updated: December 21, 2018

Record last verified: 2014-06-20

Locations

US (1)