Herceptin and GM-CSF for Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00429104

Purpose

Primary Objectives:

To determine the patient's tumor response rate that this protocol will produce.
To determine the 1 year progression-free survival that this protocol will produce.

Secondary Objective:

1. To determine whether ADCC is the mechanism of overcoming Herceptin-resistance by use of GM-CSF.

Condition	Intervention	Phase
Breast Cancer	Drug: Herceptin Drug: GM-CSF	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To see if Herceptin (trastuzumab) and GM-CSF can help to shrink or slow the growth of breast cancer that has spread outside the breast, which did not respond to earlier treatment with Herceptin. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the safety of this treatment. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	August 2002
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Herceptin + GM-CSF	Drug: Herceptin 4 mg/kg IV Over 90 Minutes Drug: GM-CSF 250 mcg/m^2 Subcutaneously

Detailed Description:

GM-CSF stimulates the immune system and may increase the effectiveness of Herceptin.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. This includes blood tests (about 2 tea spoons), and x-rays. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are found to be eligible to take part in this study, you will receive trastuzumab through a vein every week until the disease gets worse. GM-CSF will be injected under the skin at least once a day until the white blood cell count is stable. GM-CSF will also continue during the course of study until the disease progresses.

You will have further evaluation of your disease by CT scan, bone scan, chest X-ray, etc. at 2, 4, 6, 9, 12, 18, and 24 months after the start of treatment. You will have blood tests (about 2 tea spoons) at least twice a week until the appropriate dose of GM-CSF is found. The dose may increase or decrease depending on the blood test.

You will have blood (about 2 tablespoons) drawn before treatment at the 2nd and 4th month, and if the disease gets worse.

You will be removed from the study if the disease is progressing or severe side effects occur.

This is an investigational study. The FDA has approved trastuzumab and GM-CSF, but their use in this study is experimental. A total of 36 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological confirmation of invasive carcinoma of the breast.
HER-2/neu overexpression: 3+ by immunohistochemical staining or FISH (+).
Stage IV breast cancer with measurable disease.
Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.
Zubrod performance status 0 or 1.
Adequate hematological parameters (WBC > 3,000/mm3, platelet count > 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate liver function (total bilirubin, SGOT & SGPT < 3 x normal).

Exclusion Criteria:

Active Brain metastasis.
No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).
More than 2 Herceptin containing regimens in metastatic breast cancer.
Known history of HIV positive.
Chronic active hepatitis or cirrhosis.
Symptomatic pulmonary disease.
Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429104

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Bayer

Investigators

Principal Investigator:

Naoto Ueno, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Naoto Ueno, MD, PhD/Associate Professor )
Study ID Numbers:	DM01-0100
Study First Received:	January 29, 2007
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00429104
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Carcinoma of the Breast
HER-2/neu Overexpression
Herceptin

Trastuzumab
GM-CSF
Sargramostim
Leukine

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009