Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
NCT ID: NCT00009763
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
INTERVENTIONAL
2001-03-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy, cyclosporine, and paclitaxel in treating patients who have recurrent or refractory metastatic breast cancer.
Detailed Description
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* Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody m170 in combination with cyclosporine and paclitaxel in patients with recurrent or refractory metastatic breast cancer.
* Determine the preliminary efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody m170 (Y90 MOAB m170).
Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days prior to apheresis which continues daily for a maximum of 5 days. A minimum of 6 million CD34+ cells/kg must be harvested.
Patients receive oral cyclosporine every 12 hours on days -3 to 25. Patients receive unlabeled monoclonal antibody (MOAB) m170 IV followed by a tracer dose of indium In 111 MOAB m170 IV on day 0. On day 7, patients receive unlabeled MOAB m170 IV followed by Y90 MOAB m170 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9.
If needed, patients undergo autologous peripheral blood stem cell transplantation on day 21 and receive G-CSF SC daily until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB m170 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 36 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
monoclonal antibody m170
cyclosporine
paclitaxel
peripheral blood stem cell transplantation
yttrium Y 90 monoclonal antibody m170
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed metastatic breast adenocarcinoma
* Residual or recurrent disease after first-line standard chemotherapy
* Clinical evidence of metastatic disease
* Tumor cells positive for m170 immunoreactivity
* HAMA titer negative
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Not specified
Menopausal status:
* Not specified
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* LVEF at least 50% by MUGA
Pulmonary:
* FEV1 at least 65% of predicted
* FVC at least 65% of predicted
* DLCO at least 60%
Other:
* No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Chemotherapy
Chemotherapy:
* See Disease Characteristics
* At least 1 prior chemotherapy regimen for advanced disease
* Prior high-dose chemotherapy with autologous stem cell transplantation is allowed if given at least 12 months prior to study and carmustine was not used
* At least 4 weeks since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 4 weeks since prior external beam radiotherapy
* No prior radiotherapy to more than 25% of the total skeleton
Surgery:
* Not specified
Other:
* No requirement for oral anticoagulants (low-dose warfarin for central line thrombosis prophylaxis allowed)
18 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Principal Investigators
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Carol M. Richman, MD
Role: STUDY_CHAIR
University of California, Davis
Locations
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University of California Davis Cancer Center
Sacramento, California, United States
Countries
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Other Identifiers
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UCD-992080
Identifier Type: -
Identifier Source: secondary_id
NCI-V00-1640
Identifier Type: -
Identifier Source: secondary_id
CDR0000068369
Identifier Type: -
Identifier Source: org_study_id