Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
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
treatment.

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
syndrome

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:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Daniel F. Hayes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067570

NCT ID:

NCT00004893

Start Date:

December 1999

Completion Date:

February 2002

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
CCOP - Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Lombardi Cancer Center, Georgetown UniversityWashington, District of Columbia  20007
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705