Explore the NIHProtocol Details
A Multi-Center Study of Paclitaxel/Cyclophosphamide and High Dose Melphalan/Etoposide with Autologous Progenitor Cell Transplantation for the Treatment of Inflammatory Breast Cancer
This study is NOT currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
96-C-0104 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: No longer recruiting/follow-up only |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board. |
Keywords |
T-Cells; |
Recruitment Keyword(s) |
None |
Condition(s) |
Breast Neoplasm; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
Drug: Monoclonal Antibody 3A1 |
Supporting Site |
|
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.
Eligibility
ELIGIBILITY CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: | |
| Ronald E. Gress, M.D. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 3-3330 10 Center Drive Bethesda, Maryland 20892 (301) 496-1791 gressr@exchange.nih.gov |
Claude Sportes, M.D. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 3-3330 10 Center Drive Bethesda, Maryland 20892 (301) 435-5280 kastensc@mail.nih.gov |
NCI Referral Office National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office 1-888-NCI-1937 |
Clinical Trials Number:
NCT00001507
QUESTIONS?
Contact the Patient Recruitment and Public Liaison Office for:
- Details on how to participate in a study
- Details on how to refer a patient to a study
NIH Clinical Studies Information Request
Contact the Office of Communications for:
- General information about the NIH Clinical Center
Contact the Department Clinical Research Informatics, (DCRI) for:
- Technical questions about Adobe Acrobat and the PDF format
- Technical questions about this web server
