ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment

NCT00425672 | Completed Phase 1 Results

• 3 other identifiers: 6308 (FH/UWCC ID)NCI-2010-00800127
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: ONTAK may be able to help reduce the type of cells that prevent other types of immune cells from attacking the breast cancer cells. PURPOSE: This phase I/II trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced breast cancer that did not respond to previous treatment.

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Safety Evaluated by Collecting Study Related Toxicity as Assessed by CTCAE v3.0

  Subjects are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, serum albumin, complete blood counts, symptom assessment, and physical exams performed at every cycle until 3 weeks after the final dose of ONTAK. All adverse events for all systems are graded on a scale of 1-5 using CTCAE v3.0.

  7 Days after last dose of ONTAK

• Efficacy of ONTAK in Depleting T-regulatory Cells as a Decrease in Peripheral Blood Tregs Using Flow Cytometry

  The efficacy of ONTAK in depleting Tregs will be defined as a decrease in peripheral blood Tregs by 25% of each individual subject's baseline. All subjects will undergo blood draws at baseline and post ONTAK infusions at designated time points. Tregs from the peripheral blood will be quantitated using flow cytometry.

  21 days after cycle 6

Secondary Outcomes (4)

• Incidence of Interleukin-2 (IL-2) and IL-2 Receptor (IL-2R) Expression in Tumor Samples by Immunohistochemical (IHC) Analysis

  21 days after cycle 6

• Presence of Circulating sIL-2R in the Peripheral Blood

  21 days after cycle 6

• Presence of Endogenous Tumor-specific Immunity

  21 days after cycle 6

• Anti-tumor Effects of ONTAK Determined by Tumor Response and Progression

  21 days after cycle 6

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Biological: ONTAK; Other: flow cytometry; Other: immunohistochemistry staining method; Other: enzyme-linked immunosorbent assay; Other: laboratory biomarker analysis; Genetic: protein expression analysis

Interventions

ONTAK BIOLOGICAL

Given IV

Also known as: DAB389 interleukin-2, DAB389 interleukin-2 immunotoxin, DAB389-IL2, DAB389IL-2, denileukin diftitox, DAB389IL2, DABIL2

Arm I

flow cytometry OTHER

Correlative studies

Arm I

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I

enzyme-linked immunosorbent assay OTHER

Correlative studies

Also known as: ELISA

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

protein expression analysis GENETIC

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with advanced stage refractory breast cancer
• Progressive or relapsed disease following standard therapy
• Patients must have measurable disease that can include, but is not limited to bone; specifically, patients must have measurable extraskeletal disease that can be accurately measured in at least one dimension as \>= 20 mm with conventional CT techniques or \>= 10 mm with spiral CT scan; measurable (bi-dimensional) chest wall disease will also be allowed
• Patients must be at least 14 days out from last cytotoxic chemotherapy; patients on bisphosphonates are eligible
• White blood cell count (WBC) \> 3.0 THOU/ul
• ANC \> 1.0 THOU/ul
• Platelets \>= 100 THOU/ul
• Serum creatinine =\< 2.0 mg/dL or creatinine clearance (calculated) \>= 60 ml/min
• ALT/AST =\< 2.0 x upper limit of normal
• Total bilirubin =\< 1.5 x upper limit of normal
• Albumin \>= 3.0 g/dL
• Subjects must have a Performance Status Score (ECOG Scale) =\< 2
• Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
• Men and women of reproductive ability must agree to contraceptive use during the study and for 1month after ONTAK treatment is discontinued

You may not qualify if:

• Prior treatment with ONTAK (DAB389 IL-2) or DAB486 IL-2
• Known history of hypersensitivity to diphtheria toxin or IL-2
• Active autoimmune disease
• Known history of pulmonary disease except controlled asthma
• History of or pre-existing, cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization
• Pregnant or breast-feeding women

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

denileukin diftitox; Flow Cytometry; Immunohistochemistry; Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques; Immunoenzyme Techniques; Immunoassay; Immunosorbent Techniques; Molecular Probe Techniques

Results Point of Contact

• Title: Principal Investigator
• Organization: University of Washington

TrialTVG@medicine.washington.edu

Study Officials

• Lupe Salazar

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2007
• First Posted: January 23, 2007
• Study Start: September 1, 2005
• Primary Completion: April 1, 2010
• Last Updated: December 5, 2018
• Results First Posted: August 4, 2017

Record last verified: 2018-11

Locations

US (1)