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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00009763
First received: February 2, 2001
Last updated: September 19, 2013
Last verified: November 2003

February 2, 2001
September 19, 2013
March 2001
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Complete list of historical versions of study NCT00009763 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00009763
CDR0000068369, UCD-992080, NCI-V00-1640
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University of California, Davis
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Study Chair: Carol M. Richman, MD University of California, Davis
National Cancer Institute (NCI)
November 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP