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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004893
• Other study ID #: CALGB-49806
• Secondary ID: U10CA031946CLB-4
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: July 15, 2016
• Start date: December 1999
• Est. completion date: February 2002

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• recombinant interleukin-12

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	CCOP - Southwestern Vermont Regional Cancer Center	Bennington	Vermont
United States	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
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	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California San Diego Cancer Center	La Jolla	California
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	North Shore University Hospital	Manhasset	New York
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center, NY	New York	New York
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Rhode Island Hospital	Providence	Rhode Island
United States	MBCCOP - Massey Cancer Center	Richmond	Virginia
United States	Veterans Affairs Medical Center - Richmond	Richmond	Virginia
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
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 - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	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	Veterans Affairs Medical Center - Togus	Togus	Maine
United States	Lombardi Cancer Center, Georgetown University	Washington	District of Columbia
United States	Walter Reed Army Medical Center	Washington	District of Columbia
United States	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont
United States	CCOP - Christiana Care Health Services	Wilmington	Delaware
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	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression		at 6 months	No
Secondary	time to progression		Up to 1 year	No
Secondary	overall survival		Up to 1 year	No