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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol M. Richman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000068369

NCT ID:

NCT00009763

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

University of California Davis Cancer CenterSacramento, California  95817