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Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Evaluation of Novel Therapeutic Agents Against Breast Cancer: An Innovative Randomized Phase II Trial Design

OBJECTIVES: I. Determine the activity of interleukin-12 as defined by the percentage of
patients who have not progressed after 6 months of therapy. II. Compare percentage of
patients who have not progressed after six months with or without treatment regimen. III.
Determine time to progression and overall survival in this patient population after this

OUTLINE: This is a randomized study. Patients are stratified according to disease free
interval from primary diagnosis to first metastases (less than 3 years vs 3 years and
longer), estrogen receptor status (positive vs negative), and disease status (complete
response, partial response, detectable disease, or stable disease). Patients are randomized
to one of two treatment arms. Arm I: Patients begin therapy no sooner than 3 weeks and no
later than 6 weeks since last chemotherapy dose. Patients receive interleukin-12
subcutaneously twice a week. Treatment continues in the absence of disease progression or
unacceptable toxicity. Patients are followed at least every 3 months for 1 year. If no
progression after 1 year, may be followed as needed for new signs or symptoms and survival
for 5 years. Arm II: Patients are observed for 6 months. If disease progresses during first
6 months, patients may receive interleukin-12 as in arm I. Patients without disease
progression within first 6 months may also then receive interleukin-12 as in arm I.
Treatment continues in the absence of disease progression or unacceptable toxicity. Patients
are followed for toxicity only until interleukin-12 is discontinued.

PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within
8 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic or recurrent breast cancer
(not confined to breast) One prior induction chemotherapy regimen for recurrent or
metastatic disease (4 weeks of treatment for 4-6 courses) resulting in stable disease,
partial response, or complete response Pleural or peritoneal effusion palliated by
induction chemotherapy allowed No uncontrolled brain metastases Previously treated brain
metastases allowed if: No evidence of progression for at least 3 months following
radiotherapy and/or surgical treatment AND At least 30 days since dexamethasone or other
corticosteroids AND Other metastatic site exists No bone marrow or brain as only sites of
metastases No meningeal disease Hormone receptor status Estrogen receptor status known

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Menopausal status:
Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3
Absolute neutrophil count at least 1,500/mm3 Hemoglobin at least 9 g/dL (transfusion or
epoetin alfa allowed) Platelet count at least 100,000/mm3 Hepatic: SGOT/SGPT no greater
than 1.5 times upper limit of normal (ULN) Albumin at least 3.0 g/dL Bilirubin no greater
than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at
least 60 mL/min Other: No other active malignancy except nonmelanoma skin cancer Not
pregnant or nursing Fertile patients must use effective contraception No inflammatory
bowel disease or active gastric ulcer No prior autoimmune disease or immunodeficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No concurrent interleukin-11
Chemotherapy: See Disease Characteristics No concurrent chemotherapy Prior chemotherapy
with bone marrow progenitor support (bone marrow transplant and/or peripheral blood stem
cell support) allowed in adjuvant setting only (not for metastases) Endocrine therapy:
Prior hormone therapy for breast cancer allowed No concurrent hormones allowed except for
non-cancer or cancer treatment related conditions (e.g. insulin for diabetes) No
concurrent dexamethasone or other steroidal antiemetics Radiotherapy: Prior radiotherapy
allowed No concurrent radiotherapy Surgery: Not specified Other: Prior bisphosphonate
therapy allowed if started at least 3 months before study No initiation of bisphosphonate
therapy during study

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Daniel F. Hayes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

February 2002

Related Keywords:

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



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Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer Center Bennington, Vermont  05201
Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Lombardi Cancer Center, Georgetown University Washington, District of Columbia  20007
North Shore University Hospital Manhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - San Francisco San Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
Veterans Affairs Medical Center - Memphis Memphis, Tennessee  38104
Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
University of Illinois at Chicago Health Sciences Center Chicago, Illinois  60612
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia, Missouri  65201
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Veterans Affairs Medical Center - Buffalo Buffalo, New York  14215
Veterans Affairs Medical Center - Syracuse Syracuse, New York  13210
Veterans Affairs Medical Center - Durham Durham, North Carolina  27705