- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00020176
Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation after an immunoablative conditioning regimen to induce a state of mixed host/donor chimerism in patients with metastatic breast cancer.
- Determine the ability of this treatment regimen to induce an allogeneic graft-versus-tumor response in these patients.
- Determine the feasibility of giving other approved therapies to these patients at the first sign of disease progression in order to stabilize or produce a minimal or partial response.
OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 2 courses.
Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40.
Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42, 70, and 98.
Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.
PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Bethesda, Maryland, United States, 20892
- NCI - Center for Cancer Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Stage IV breast cancer
- Measurable disease
Progressive disease
- Increase in disease mass or less than partial response to therapy
At least one prior chemotherapy regimen for metastatic disease and progressed
- Must have received prior therapy with a taxane and an anthracycline
- Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting
- Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting
- Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting
- Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus)
Hormone receptor status:
- Estrogen receptor status known
- Progesterone receptor status known
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Life expectancy:
- More than 6 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin ≤ 2 mg/dL
- SGOT < 4 times upper limit of normal
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal:
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
Cardiovascular:
- Left ventricular ejection fraction > 45%
Pulmonary:
- DLCO ≥ 50% of predicted
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- Recovered from prior stem cell transplantation
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- See Disease Characteristics
- No concurrent steroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael R. Bishop, MD, National Cancer Institute (NCI)
Publications and helpful links
General Publications
- Bishop MR. Nonmyeloablative allogeneic hematopoietic stem cell transplantation for metastatic breast cancer. Clin Breast Cancer. 2003 Apr;4(1):39-45. doi: 10.3816/cbc.2003.n.010.
- Bishop MR, Fowler DH, Marchigiani D, Castro K, Kasten-Sportes C, Steinberg SM, Gea-Banacloche JC, Dean R, Chow CK, Carter C, Read EJ, Leitman S, Gress R. Allogeneic lymphocytes induce tumor regression of advanced metastatic breast cancer. J Clin Oncol. 2004 Oct 1;22(19):3886-92. doi: 10.1200/JCO.2004.01.127. Epub 2004 Aug 16.
- Bishop MR, Steinberg SM, Gress RE, Hardy NM, Marchigiani D, Kasten-Sportes C, Dean R, Pavletic SZ, Gea-Banacloche J, Castro K, Hakim F, Krumlauf M, Read EJ, Carter C, Leitman SF, Fowler DH. Targeted pretransplant host lymphocyte depletion prior to T-cell depleted reduced-intensity allogeneic stem cell transplantation. Br J Haematol. 2004 Sep;126(6):837-43. doi: 10.1111/j.1365-2141.2004.05133.x.
- Bishop MR, Kasten-Sportes C, Dean R, et al.: Preemptive DLI after T cell-depleted reduced-intensity allogeneic HSCT for metastatic breast cancer: effect on engraftment, GVHD, and anti-tumor response. [Abstract] Blood 102 (11): A- 5567, 2003.
- Bishop MR, Marchigiani D, Grasmeder S, et al.: Demonstration of clinical responses to adoptive cellular therapy using allogeneic T cells in metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-657, 2003.
- Bishop MR, Marchigiani D, Odom J, et al.: Contribution of T cells to engraftment: a comparison of T cell depleted vs. T cell replete allografts after reduced-intensity conditioning. [Abstract] Blood 102 (11): A-2447, 2003.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclophosphamide
- Fludarabine
- Fludarabine phosphate
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CDR0000067899
- NCI-00-C-0119
- NCI-1027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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