Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca

NCT00784524 | Terminated Phase 2 Results DMC

• 2 other identifiers: 2007LS0940802M25946
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with aldesleukin works in treating women with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease Response

  Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), \>=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

  Up to 2 years

Secondary Outcomes (4)

• Immune Response

  48 hours

• Progression-free Survival

  Up to 1 year

• Overall Survival

  1 Year

• Overall Survival

  2 years

Study Arms (1)

LMI Vaccination + IL-2

EXPERIMENTAL

Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.

Biological: allogeneic large multivalent immunogen breast cancer vaccine; Biological: aldesleukin

Interventions

allogeneic large multivalent immunogen breast cancer vaccine BIOLOGICAL

Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10\^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.

Also known as: LMI

LMI Vaccination + IL-2

aldesleukin BIOLOGICAL

Subcutaneous aldesleukin (10 x 10\^6 International Units) will be given on day 7 and day 8 after each LMI injection.

Also known as: Interleukin-2, IL-2, Proleukin

LMI Vaccination + IL-2

Eligibility Criteria

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

You may qualify if:

• Stage IV, metastatic breast cancer, confirmed by histology or cytology.
• Disease must be refractory to hormone therapy for tumors that estrogen and/or progesterone receptor positive
• Disease must be refractory to trastuzumab for tumors that are HER2 positive
• Disease must be responsive to chemotherapy such that regression or at least stabilization occurs
• Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
• Measurement of regressed or stable disease must be confirmed by repeat evaluation no less than 4 weeks after the initial determination.
• Prior systemic chemotherapy, immunotherapy, biological therapy, or investigational drug therapy is allowed if at least 4 weeks since last treatment.
• Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
• There is no limit as to the number of previous chemotherapy regimens received.
• Disease status may be measurable or non-measurable
• Karnofsky performance status \>70%
• Women, age 18 years or older
• Adequate organ function within 14 days of study registration including the following:
• Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥75 x 10\^9/L, and hemoglobin ≥ 8.0 g/dL
• Hepatic: bilirubin ≤ 3 times the upper limit of normal (× ULN) for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver; aspartate transaminase (AST) ≤ 2.5 × ULN for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver

You may not qualify if:

• History of untreated or active brain metastases or positive brain scan at enrollment. Patients with previously treated brain metastases are eligible if stable by CT or MRI for at least 3 months.
• Concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
• Active infection
• Solid organ transplantation or autoimmune diseases requiring systemic immunosuppressive therapy; however, topical or inhalational steroids are allowed.
• Symptomatic pulmonary disease (symptoms of dyspnea or rales, wheezes or rhonchi on physical exam) will require pulmonary function testing (PFTs). Those with FEV1 \<50% of predicted or corrected DLCO \<50% are not eligible.
• Patients with cardiac disease such as recent myocardial infarction (\< 3 months prior), unstable angina, or heart failure requiring medical intervention will undergo cardiac evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium stress test as indicated to evaluate cardiac risks. Those patients with exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram \< 40% are not eligible.
• Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative, is a contraindication (taken from tetanus toxoid package insert).
• The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a contraindication to further use (taken from tetanus toxoid package insert).
• Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy category C - risk in pregnancy cannot be ruled out.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

aldesleukin; Interleukin-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Douglas Yee
• Organization: Masonic Cancer Center, University of Minnesota

yeexx006@umn.edu

612-626-8487

Study Officials

• Douglas Yee, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2008
• First Posted: November 4, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-05

Locations

US (1)