Completed

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

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What is being tested

tamoxifen citrate

+ busulfan

+ thiotepa

DrugBiologicalProcedureRadiation
Who is being recruted

Breast Diseases+5

+ Neoplasms

+ Neoplasms by Site

From 19 to 65 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 1997
See protocol details

Summary

Principal SponsorFred Hutchinson Cancer Center
Last updated: July 12, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00003199
Principal SponsorFred Hutchinson Cancer Center
Last updated: July 12, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast NeoplasmsBreast Neoplasms, MaleInflammatory Breast Neoplasms

Criteria

15 inclusion criteria required to participate
Hepatic function: Bilirubin =< 2 mg%; SGOT or SGPT =< 2.5 x institutional normal

Can start therapy 30 to 100 days after transplant

Renal function: Creatinine =< 2.0 mg/dl or a creatinine clearance >= 50 mg/min

Karnofsky performance status > 60

Show More Criteria

22 exclusion criteria prevent from participating
Patients with a history of seizures

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%

Patient is pregnant

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
See Detailed Description.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium

Seattle, United StatesOpen Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium in Google Maps
CompletedOne Study Center