Trials / Completed

CompletedNCT00003199

Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer

A Phase II Trial for Patients With Inflammatory (Stage IIIB) and Responsive Metastatic Stage IV Breast Cancer Using Busulfan, Melphalan and Thiotepa Followed by Autologous or Syngeneic PBSC Rescue and 12 Weeks of Post-Engraftment Immunotherapy With Low-Dose IL-2 and GM-CSF

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 50 (actual)

Sponsor: Fred Hutchinson Cancer Center · Academic / Other
Sex: All
Age: 19 Years – 65 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells

Detailed description

PRIMARY OBJECTIVES: I. To determine the event-free survival and survival of patients treated for inflammatory (Stage IIIb) and responsive stage IV breast cancer with BUMELTT and PBSC support and low dose immunotherapy with IL2 and GM-CSF. SECONDARY OBJECTIVES: II. To determine the toxicity of a combination of low-dose IL-2 and GM-CSF in patients following HDC with BUMELTT and PBSC support. OUTLINE: PREPARATIVE REGIMEN: Patients receive busulfan orally (PO) once every 6 hours on days -8, -7, and -6; melphalan IV over 30 minutes on days -5 and -4; and thiotepa IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell infusion on day 0. POST-TRANSPLANT THERAPY: All patients receive tamoxifen citrate\* PO once daily beginning prior to aldesleukin (IL-2) and sargramostim (GM-CSF) therapy and continuing for 5 years or until relapse (estrogen receptor \[ER\]- or progesterone receptor \[PR\]-positive patients) OR until completion of IL-2/GM-CSF therapy (ER-negative or PR-negative patients). Eligible patients receive IL-2 subcutaneously (SC) daily and GM-CSF SC 3 times weekly for 12 weeks beginning 30-100 days after transplantation. Patients may receive radiotherapy after completion of IL-2/GM-CSF treatment if no prior radiotherapy was given before transplantation. \*Stage IV patients not receiving IL-2/GM-CSF therapy who received tamoxifen citrate as part of adjuvant therapy and subsequently failed, receive oral anastrozole once daily for 5 years or until progression instead of tamoxifen. \[\*For postmenopausal patients, the choice and duration of hormonal therapy given in addition to or an alternative to tamoxifen therapy will be at the physician's discretion\] Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

Interventions

Type	Name	Description
DRUG	tamoxifen citrate	Given orally
DRUG	busulfan	Given orally
DRUG	thiotepa	Given IV
DRUG	melphalan	Given IV
BIOLOGICAL	aldesleukin	Given SC
BIOLOGICAL	sargramostim	Given SC
PROCEDURE	peripheral blood stem cell transplantation	Undergo autologous peripheral blood stem cell infusion
RADIATION	radiation therapy	May undergo radiotherapy after completion of IL-2/GM-CSF

Timeline

Start date: 1997-11-01
Primary completion: 2009-12-01
Completion: 2009-12-01
First posted: 2003-01-27
Last updated: 2017-07-12
Results posted: 2017-05-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00003199. Inclusion in this directory is not an endorsement.