Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer

NCT ID: NCT00004893

Last Updated: 2016-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2002-02-28

Brief Summary

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill breast cancer cells.

PURPOSE: Randomized phase II trial to study the effectiveness of interleukin-12 in treating patients who have metastatic or recurrent breast cancer.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IL12 Therapy

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.

Group Type: EXPERIMENTAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Observation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

recombinant interleukin-12

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel F. Hayes, MD

Role: STUDY_CHAIR

University of Michigan Rogel Cancer Center

Locations

Veterans Affairs Medical Center - Birmingham

Birmingham, Alabama, United States

University of California San Diego Cancer Center

La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Lombardi Cancer Center, Georgetown University

Washington D.C., District of Columbia, United States

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

University of Illinois at Chicago Health Sciences Center

Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital)

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Veterans Affairs Medical Center - Togus

Togus, Maine, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial)

Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

CCOP - Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Veterans Affairs Medical Center - Buffalo

Buffalo, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

CCOP - North Shore University Hospital

Manhasset, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New York Presbyterian Hospital - Cornell Campus

New York, New York, United States

Mount Sinai Medical Center, NY

New York, New York, United States

State University of New York - Upstate Medical University

Syracuse, New York, United States

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

Syracuse, New York, United States

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Veterans Affairs Medical Center - Durham

Durham, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Veterans Affairs Medical Center - Memphis

Memphis, Tennessee, United States

CCOP - Southwestern Vermont Regional Cancer Center

Bennington, Vermont, United States

Vermont Cancer Center

Burlington, Vermont, United States

Veterans Affairs Medical Center - White River Junction

White River Junction, Vermont, United States

Veterans Affairs Medical Center - Richmond

Richmond, Virginia, United States

MBCCOP - Massey Cancer Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLB-49806

Identifier Type: -

Identifier Source: secondary_id

CDR0000067570

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-49806

Identifier Type: -

Identifier Source: org_study_id