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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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 and colony-stimulating factors such as sargramostim may help a person's immune system kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation followed by interleukin-2 and sargramostim in treating patients who have inflammatory stage IIIB or metastatic stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: aldesleukin Biological: sargramostim Drug: busulfan Drug: melphalan Drug: tamoxifen citrate Drug: thiotepa Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 With 12 Weeks of Post-Engraftment Immunotherapy With Low-Dose IL-2 and GM-CSF |
| Estimated Enrollment: | 70 |
| Study Start Date: | November 1997 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Peripheral blood stem cells (PBSC) are collected from the patient following stimulation with cyclophosphamide/paclitaxel/filgrastim (G-CSF) according to FHCRC 506 protocol or an approved FHCRC cytokine mobilization study. Patients must receive 1 course of cyclophosphamide and paclitaxel if cytokines alone are used to mobilize cells (FHCRC-506.03 protocol). G-CSF alone will be used to collect syngeneic PBSC (FHCRC-753).
Patients receive oral busulfan every 6 hours on days -8, -7, and -6. Melphalan IV is given on days -5 and -4 beginning at least 12 hours after busulfan. Thiotepa IV is given on days -3 and -2 followed by PBSC infusion on day 0 beginning 36-48 hours after the last dose of thiotepa.
All patients receive oral tamoxifen daily after transplant for 5 years or until relapse. Eligible patients receive interleukin-2 (IL-2) subcutaneously (SQ) daily plus sargramostim (GM-CSF) SQ on Monday, Wednesday, and Friday for 12 weeks beginning 30-100 days after transplantation. Patients with negative estrogen and progesterone status may discontinue tamoxifen therapy following IL-2/GM-CSF treatment. Patients receive radiotherapy after IL-2/GM-CSF treatment if no prior radiotherapy was given before transplantation.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 70 patients will be accrued for this study over 2 years.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage IIIB inflammatory breast cancer
Responsive stage IV breast cancer metastatic to soft tissue and/or bone
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Leona A. Holmberg, MD, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000066035, FHCRC-1229.00, PSOC-1605, NCI-G98-1399 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003199 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IIIB breast cancer inflammatory breast cancer |
|
Anti-Infective Agents Melphalan Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Alkylating Agents |
Breast Diseases Estrogen Antagonists Anti-HIV Agents Skin Diseases Antineoplastic Agents, Hormonal Breast Neoplasms Antiviral Agents Immunosuppressive Agents Tamoxifen Pharmacologic Actions Thiotepa Neoplasms Aldesleukin Busulfan Myeloablative Agonists |
