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Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer


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 (IV) 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 computed tomography-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 UT MD Anderson Cancer Center.


Inclusion Criteria:



1. Histological confirmation of invasive carcinoma of the breast.

2. HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ
hybridization (FISH) (+).

3. Stage IV breast cancer with measurable disease.

4. Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin
alone. No more than two Herceptin containing regimens.

5. Zubrod performance status 0 or 1.

6. Adequate hematological parameters (White Blood cells-WBC > 3,000/mm3, platelet count
> 100,000/mm3), adequate renal function (serum creatinine < 2.0 mg/dl), adequate
liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine
aminotransferase (ALT or SGPT) < 3 x normal).

Exclusion Criteria:

1. Active Brain metastasis.

2. No measurable disease at the time of registration (e.g. bone only, leptomeningeal
disease alone or pleural effusion alone).

3. More than 2 Herceptin containing regimens in metastatic breast cancer.

4. Known history of HIV positive.

5. Chronic active hepatitis or cirrhosis.

6. Symptomatic pulmonary disease.

7. Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week
prior to registration.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Tumor Response (Stable Disease)

Outcome Description:

Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Naoto Ueno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

DM01-0100

NCT ID:

NCT00429104

Start Date:

August 2002

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Carcinoma of the Breast
  • HER-2/neu Overexpression
  • Herceptin
  • Trastuzumab
  • GM-CSF
  • Sargramostim
  • Leukine
  • Breast Neoplasms

Name

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