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Phase 2 N=50 Treatment

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

Estrogen Receptor-negative Breast Cancer · Estrogen Receptor-positive Breast Cancer · Inflammatory Breast Cancer · Male Breast Cancer · Progesterone Receptor-negative Breast Cancer

Enrolled (actual)
50
Serious AEs
4.0%
Results posted
May 2017
Primary outcome: Primary: Event-free Survival — 11; 9 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
tamoxifen citrate (Drug); busulfan (Drug); thiotepa (Drug); melphalan (Drug); aldesleukin (Biological); sargramostim (Biological); peripheral blood stem cell transplantation (Procedure); radiation therapy (Radiation)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
Fred Hutchinson Cancer Center
Primary completion
Dec 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Event-free Survival
11; 9
SECONDARY
Overall Survival
18
SECONDARY
Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF
6

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

Eligibility Criteria

Inclusion Criteria

  • 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 = = 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 = 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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