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| Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002942 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral stem cell transplantation following carboplatin in treating patients with breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Therapy in Poor Prognosis Breast Cancer |
| Study Start Date: | June 1996 |
OBJECTIVES: I. Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP as hematopoietic support following high dose CTCb for patients with poor prognosis breast cancer. II. Compare the complications of these two methods of hematopoietic progenitor cell collections. III. Compare Stage IV patients with bone or bone marrow involvement (assigned to PBPC collections) with Stage IV patients randomized to PBPC collections relative to the number of leukaphereses needed to collect the required number of progenitor cells as well as assess engraftment rates between these two groups. IV. Assess the response to high dose CTCb in this group of patients.
OUTLINE: All patients will receive G-CSF priming therapy for 5 consecutive days. Patients will then be randomized into two treatment arms: Arm 1 consists of autologous PBPC collection Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell collection, all patients will receive high dose CTCb therapy by continuous infusion for 5 days, followed by autologous hematopoietic progenitor cell infusion at least three days later. G-CSF will also be given after infusion until ANC count is over 5,000 or over 1,000 for 3 consecutive days.
PROJECTED ACCRUAL: 66 patients will be accrued at a rate of 24 per year.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including poorly differentiated histology, high mitotic rate, hormone receptor negative, high S phase) with at least three involved axillary lymph nodes, estimated five year relapse free survival rate less than 50%, and does not qualify for higher priority protocol treatments No central nervous system involvement
PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3 Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60 mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or severe cardiovascular disease, including recent myocardial infarction, congestive heart failure, angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and spirometry at least 50% of predicted Other: Not HIV positive Not HBsAG positive Not pregnant Must have functioning central venous catheter No active infection No uncontrolled diabetes mellitus No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least 5 years
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Contacts and Locations| United States, North Carolina | |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Study Chair: | David D. Hurd, MD | Wake Forest University |
More Information
| Study ID Numbers: | CDR0000065391, CCCWFU-95496, NCI-G97-1145 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002942 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IV breast cancer stage IIIA breast cancer stage IIIB breast cancer |
|
Immunologic Factors Skin Diseases Breast Neoplasms Antineoplastic Agents, Alkylating Carboplatin Cyclophosphamide |
Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Breast Diseases Thiotepa |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Carboplatin Immunosuppressive Agents Pharmacologic Actions |
Thiotepa Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
