Filgrastim Plus Chemotherapy Compared With Filgrastim Alone In Treating Women Undergoing Peripheral Stem Cell Transplantation For Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Colony-stimulating factors such as filgrastim may increase the
      number of immune cells found in bone marrow or peripheral blood and may help a person's
      immune system recover from the side effects of chemotherapy. Peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus
      filgrastim with filgrastim alone in treating women undergoing peripheral stem cell
      transplantation for stage II, stage III, or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      I. Determine whether high dose chemotherapy in addition to growth factors increases the yield
      of filgrastim mobilized progenitor cells.

      II. Determine the kinetics of hematopoietic reconstitution following myeloablative therapy
      and mobilized blood stem cell transplantation.

      III. Determine whether the use of high dose chemotherapy in addition to growth factors for
      mobilization of stem cells reduces risk of relapse as measured by time to progression in
      responsive relapsed breast cancer patients receiving autologous peripheral blood stem cell or
      bone marrow transplants.

      IV. Determine the morbidity and cost differences of the use of high dose chemotherapy plus
      growth factors compared to growth factors alone for mobilization of peripheral blood
      progenitors and treatment of breast cancer with high dose chemotherapy.

      OUTLINE: Patients will be randomized into 2 groups. Group 1 patients undergo CVP chemotherapy
      treatment by vein (IV) on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.
      Filgrastim SC (subcutaneously) is given on day 4 every 12 hours until completion of
      apheresis. Group 2 patients only receive filgrastim SC given on day 1 every 12 hours until
      completion of apheresis. Stem cells are removed beginning on day 4 for a maximum of 6 days.
      Upon recovery of hematopoiesis patients then receive high IV doses of CBT chemotherapy with
      CTX, carmustine, and thiotepa for 3 days, followed 4 days later by autologous stem cell
      reinfusion. Beginning on day of reinfusion, filgrastim is given bid until WBC reaches a safe
      level. Patients are followed for 90 days posttransplant, and then followed indefinitely for
      antitumor response and time to progression.

      PROJECTED ACCRUAL: This study will include about 218 patients.
    

Intervention name(s): Filgrastim (G-CSF); Carmustine; Cisplatin; Cyclophosphamide (CTX); Etoposide; Thiotepa; Peripheral Blood Stem Cell Transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): For group one (Filgrastim + Chemotherapy), given under the skin (SC) on day 4 every 12 hours until completion of apheresis; for group two (Filgrastim alone), beginning on day of reinfusion twice a day (bid) until white blood count (WBC) reaches a safe level.; Upon recovery of hematopoiesis patients then receive high by vein (IV) doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days; As part of CVP chemotherapy treatment by vein (IV) on days 1-3.; In group one (Filgrastim + Chemotherapy) as part of CVP chemotherapy treatment by vein (IV) on days 1-3; and group two (Filgrastim alone), upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.; CVP chemotherapy treatment IV on days 1-3, with cyclophosphamide (CTX), etoposide, and cisplatin.; Upon recovery of hematopoiesis receive high IV doses of CBT chemotherapy with CTX, carmustine, and thiotepa for 3 days.; Infusion of stem cells on Day 0.
Other intervention name(s): Neupogen; G-CSF; BCNU; BiCNU; Platinol-AQ; Platinol; CDDP; Cytoxan; Neosar; VePesid; PBSCT; Stem Cell Transplant
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Carmustine; Cisplatin; Etoposide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer