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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00003199 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: tamoxifen citrate Drug: busulfan Drug: thiotepa Drug: melphalan Biological: aldesleukin Biological: sargramostim Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 70 |
| Study Start Date: | November 1997 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
See Detailed Description.
|
Drug: tamoxifen citrate
Given orally
Other Names:
Drug: busulfan
Given orally
Other Names:
Drug: thiotepa
Given IV
Other Names:
Drug: melphalan
Given IV
Other Names:
Biological: aldesleukin
Given SC
Other Names:
Biological: sargramostim
Given SC
Other Names:
Procedure: peripheral blood stem cell transplantation
Undergo autologous peripheral blood stem cell infusion
Other Names:
Radiation: radiation therapy
May undergo radiotherapy after completion of IL-2/GM-CSF
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium | |
| Seattle, Washington, United States, 98109 | |
| Principal Investigator: | Leona Holmberg | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
More Information
| Responsible Party: | Holmberg, Leona, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00003199 History of Changes |
| Other Study ID Numbers: | PSOC 1605, NCI-2010-00728 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 8, 2011 |
| Health Authority: | United States: Federal Government |
|
Breast Neoplasms Breast Neoplasms, Male Inflammatory Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Busulfan Melphalan Thiotepa Aldesleukin Interleukin-2 Tamoxifen Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators |