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Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
conventional surgery
neoadjuvant therapy
thermal ablation therapy
Sponsored by
Imunon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed primary breast cancer by core needle biopsy T1a, b, c, or T2 Diagnosis not made with a lumpectomy or incisional biopsy Candidate for breast conservation surgery (lumpectomy/radiotherapy) Tumor measurable by breast ultrasound No metastatic disease, including skin metastases No bilateral breast cancer No high-probability of extensive intraductal disease in situ No clinical fixation to the pectoralis major muscle or skin No involvement of the nipple No inflammatory breast cancer No multicentric disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Platelet count at least 100,000/mm^3 (no thrombocytopenia) No bleeding disorders Hepatic: PT, INR, and PTT less than 1.5 times normal Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times normal No coagulopathy No liver disease Renal: BUN less than 30 mg/dL Creatinine less than 1.9 mg/dL No renal insufficiency Cardiovascular: No pacemakers or defibrillators No clinically significant heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception, including 1 barrier method Able to tolerate prone position and breast compression No breast implants No prior collagen vascular disease No other factor or condition (other than tumor size) that would preclude lumpectomy No mental condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No prior participation in this study More than 30 days since prior participation in another clinical study No concurrent anticoagulants

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • St. Joseph Hospital Regional Cancer Center - Orange
  • Comprehensive Breast Center of Coral Springs
  • Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
  • Mroz-Baier Breast Care Center
  • Breast Care Specialists, P.C.
  • Royal Bolton Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 13, 2002
Last Updated
November 5, 2013
Sponsor
Imunon
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1. Study Identification

Unique Protocol Identification Number
NCT00036998
Brief Title
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
Official Title
A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Unknown status
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Imunon

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.
Detailed Description
OBJECTIVES: Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer. Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens. Compare the percentage of pathological cell death in women treated with these regimens. Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens. Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor classification (T1 vs T2) and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I:Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of undue heating of the skin, a tumor temperature of 48-52° C is targeted and maintained for an equivalent thermal dose of 140-180 minutes. Within 60 days of thermotherapy, patients undergo lumpectomy. Arm II: Patients undergo lumpectomy only. Patients are followed at 30 and 90 days after surgery, and then at the discretion of the physician. PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
thermal ablation therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed primary breast cancer by core needle biopsy T1a, b, c, or T2 Diagnosis not made with a lumpectomy or incisional biopsy Candidate for breast conservation surgery (lumpectomy/radiotherapy) Tumor measurable by breast ultrasound No metastatic disease, including skin metastases No bilateral breast cancer No high-probability of extensive intraductal disease in situ No clinical fixation to the pectoralis major muscle or skin No involvement of the nipple No inflammatory breast cancer No multicentric disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Platelet count at least 100,000/mm^3 (no thrombocytopenia) No bleeding disorders Hepatic: PT, INR, and PTT less than 1.5 times normal Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times normal No coagulopathy No liver disease Renal: BUN less than 30 mg/dL Creatinine less than 1.9 mg/dL No renal insufficiency Cardiovascular: No pacemakers or defibrillators No clinically significant heart disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception, including 1 barrier method Able to tolerate prone position and breast compression No breast implants No prior collagen vascular disease No other factor or condition (other than tumor size) that would preclude lumpectomy No mental condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No prior participation in this study More than 30 days since prior participation in another clinical study No concurrent anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E. Gannon, MD
Organizational Affiliation
Imunon
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
St. Joseph Hospital Regional Cancer Center - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Comprehensive Breast Center of Coral Springs
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Mroz-Baier Breast Care Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Breast Care Specialists, P.C.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Royal Bolton Hospital
City
Bolton, Lancashire
State/Province
England
ZIP/Postal Code
BL4 0JR
Country
United Kingdom

12. IPD Sharing Statement

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Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

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