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

Completed · Phase 2

Conditions studied: Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, Inflammatory Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer

In brief

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

Key facts

Study ID

NCT00003199

Run by

Fred Hutchinson Cancer Center

People needed

50

Starts

1997-11-01

Expected to finish

2009-12-01

Last updated by the study team

2017-07-12

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with inflammatory (stage IIIb) or responsive stage IV breast cancer with metastasis to soft tissue and/or bone; responsive stage IV disease is defined as patients who achieve a PR (>= 50% reduction in measurable tumor burden) or CR following initial chemotherapy for metastatic disease or patients with locally recurrent disease (chest wall/axillary nodes) who are rendered disease-free following surgery or radiation therapy without receiving chemotherapy; bone disease is categorized as responsive if there is demonstrated sclerosis of prior lesions with no new lesions
• Patients should have received 4-7 cycles of an Adriamycin and/or taxane-based regimen for stage IIIb or stage IV disease; locally recurrent (chest wall/axillary nodes) patients rendered NED by RT or surgery do not need to receive chemotherapy for stage IV disease prior to Cytoxan/Taxol
• Patient has received Cytoxan 4 gm/m\^2 x 1 and Taxol 250 mg/m\^2 x 1 per FHCRC protocol 506.03; Cytoxan/Taxol must be given after all other chemotherapy is completed and before transplant
• Stem cells were collected after mobilization with Cytoxan/Taxol or after mobilization from an FHCRC approved cytokine protocol; if syngeneic collection, PBSC's were collected by using G-CSF according to FHCRC protocol 753; patient has an adequate number of peripheral blood stem cells stored (>= 2.5 x 10\^6 CD34+ cells/kg)
• The patient must have the capacity to give informed consent; the patient must have signed an approved consent form conforming with federal and institutional guidelines
• Hepatic function: Bilirubin =< 2 mg%; SGOT or SGPT =< 2.5 x institutional normal
• Renal function: Creatinine =< 2.0 mg/dl or a creatinine clearance >= 50 mg/min
• Pre-Study tests have been performed as outlined in the Study Calendar
• Patients will begin IL-2/GM-CSF therapy if they meet the following criteria post-transplant:
• Can start therapy 30 to 100 days after transplant
• Karnofsky performance status > 60
• ANC > 1,000 cells/mm\^3 and platelets > 30,000/cells/mm\^3 (transfusion independent) for at least 5 days before starting therapy
• Total bilirubin =< 2.5 x upper limit of normal
• SGOT =< 2.5 x upper limit of normal
• Creatinine =< 2.0 mg/dl

You may not qualify if…

• Patients with a Karnofsky Performance Score less than 70
• Patients with a left ventricular ejection fraction less than 50 % (LVEF must be performed in patients with symptoms of CHF, abnormal cardiac exam or history of Adriamycin therapy total dose > 400 mg/m\^2)
• Patient is pregnant
• Patient is seropositive for the human immunodeficiency virus
• Patients with a history of seizures
• Patients with hypersensitivity to E.coli preparations
• Patients with active auto-immune disease
• Patients with clinically significant pulmonary disease, i.e., diffusion capacity corrected < 60% of predicted; patients with pulmonary problems should be evaluated with appropriate pulmonary studies and/or consult
• Patients with a history of CNS lesion (brain or carcinoid meningitis)
• Patients with significant active infection precluding transplant
• Patients who have had more than one prior chemotherapy regimen for stage IV disease or a prior transplant for any stage disease
• Patients who have had CD34+ selection of their PBSC products
• Patients will not receive IL-2/GM-CSF therapy if they:
• Are > 100 days from transplant
• Have documented disease progression after transplant
• Have an active infection
• Manifested cardiac complications during the initial transplant period, including arrhythmias (that required therapy), congestive heart failure, angina, myocardial infarct, or decreased LVEF to < 45%
• Currently have pericardial effusions, pleural effusions or ascites
• Manifested pulmonary toxicity during the initial transplant period and have a diffusion capacity corrected =< 60%
• Are on steroids
• Currently have a Grade 3 toxicity from BuMelTT
• If the patient does not wish to receive the therapy

Where it is running

• Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.