NCT00001507

Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer

Completed Phase 1 Last updated 21 December 2018

What this trial tests

Phase 1 trial testing Monoclonal Antibody 3A1 in Breast Neoplasm in 107 participants. Completed in 20 June 2014.

Timeline

12 July 1996

Primary endpoint
30 June 1998

20 June 2014

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	107
Start date	12 July 1996
Primary completion	30 June 1998
Estimated completion	20 June 2014
Sites	1 location across United States

Drugs / interventions tested

• Monoclonal Antibody 3A1 — full drug profile →
• Monoclonal Antibody 95-5-49 — full drug profile →
• Monoclonal Antibody 95-6-22 — full drug profile →
• Baxter Isolex 3001 Stem Cell Selection System
• Ceprate SC

Conditions studied

• Breast Neoplasm — all drugs for Breast Neoplasm →
• Neoplasm Metastasis — all drugs for Neoplasm Metastasis →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Breast Neoplasm or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.