Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer - Full Text View

Sponsor:	University of California, Davis
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00009763

Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for metastatic breast cancer.

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.

Condition	Intervention	Phase
Breast Cancer	Biological: filgrastim Biological: monoclonal antibody m170 Drug: cyclosporine Drug: paclitaxel Procedure: peripheral blood stem cell transplantation Radiation: yttrium Y 90 monoclonal antibody m170	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Combined Modality Radioimmunotherapy For Metastatic Breast Adenocarcinoma With Two Cycles Of Escalating Dose 90Y-DOTA-Peptide-m170 and Fixed, Low Dose Paclitaxel With Blood Stem Cell Support And Cyclosporin For HAMA Suppression

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Cyclosporine Cyclosporin Filgrastim Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2001

Detailed Description:

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009763

Locations

United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Study Chair:

Carol M. Richman, MD

University of California, Davis

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068369, UCD-992080, NCI-V00-1640
Study First Received:	February 2, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00009763 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclosporins
Antibodies, Monoclonal
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Dermatologic Agents
Breast Diseases
Immunoglobulins

Skin Diseases
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Antibodies
Neoplasms
Paclitaxel
Tubulin Modulators
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 05, 2009