Phase 1/2 Study of ThermoDox With Approved Hyperthermia in Treatment of Breast Cancer Recurrence at the Chest Wall

NCT00826085 | Completed Phase 1

• 1 other identifier: 105-08-201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief Summary

This is a research study to evaluate the effects of ThermoDox in combination with therapeutic heating of the chest wall in the treatment of recurrent regional breast cancer. The purpose of this study is to evaluate the bioequivalence of ThermoDox and measure efficacy in recurrent chest wall patients.

Conditions

Breast Cancer

Keywords

Breast Cancer; Recurrent Chest Wall Cancer; Loco-regional Recurrent Breast Cancer; Breast Cancer Recurrence at the Chest Wall

Outcome Measures

Primary Outcomes (2)

• To determine the bioequivalence of ThermoDox when used with hyperthermia among patients with RCW breast cancer.

  PK collection at Cycle 1 and Cycle 2

• To determine efficacy of ThermoDox in combination with Hyperthermia

  Efficacy assessed at Cycle 3, Cycle 5 and End of Treatment

Secondary Outcomes (1)

• To evaluate the safety of ThermoDox in combination with Hyperthermia

  Through 6 treatment Cycles

Study Arms (1)

Thermodox in combination with hyperthermia

EXPERIMENTAL

Single arm study

Drug: ThermoDox in combination with Microwave Hyperthermia (heat)

Interventions

ThermoDox in combination with Microwave Hyperthermia (heat) DRUG

ThermoDox is a 30 minute intravenous infusion followed by hyperthermia within 60 minutes of infusion completion. Hyperthermia is a therapy used to heat tumors for 60 minutes. Using heat energy, the tumor is heated to a certain temperature. The heat can damage cancer cells at levels that are usually safe for normal cells and can be used to attack cancer in four major ways: 1) heat damages or weakens the cells of the tumor; 2) heat increase blood flow through the weakened tumor; 3) increased blood flow raises oxygen levels in tumors; and 4) when the body senses fever it can stimulate the nature immune system. All patients will receive up to six ThermoDox/hyperthermia treatments at 21-day intervals.

Thermodox in combination with hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented recurrent/metastatic adenocarcinoma of the breast with a recurrence on the chest wall (or its overlying skin):
• Subjects with ulcerative chest wall disease defined as non-healing wounds consistent with cancer are eligible.
• Subjects with prior skin changes consistent with inflammatory breast carcinoma are eligible.
• Breast carcinoma for medical reasons not being resected
• Tumor thickness must be clinically indicated for hyperthermia therapy, as measured by clinical exam or imaging studies (CT or MRI). The target local tumor lesion(s) must be able to be covered within two hyperthermia fields of treatment.
• Disease that has progressed despite other available standard treatment options, based on what is clinically indicated according to the investigator's clinical and medical judgment, including:
• One or more radiation treatment(s) to the chest wall or breast up to a maximum prior dose of 12,000 cGy in the hyperthermia field (not administered less than 28 days prior to enrollment).
• Subjects who have previously received hyperthermia in conjunction with either radiation therapy or chemotherapy are eligible.
• Subjects may have distant metastasis, including brain metastases. Subjects with known brain metastases are eligible if:
• They have received standard anti-tumor treatment for their brain metastases without encephalopathy;
• Their neurological function is stable for at least 30 days and either off steroid therapy or on a stable steroid regimen.
• Non-pregnant female at least 18 years of age. If the subject is of child-bearing age, must have a negative serum pregnancy test at baseline and must agree to practice an acceptable form of birth control while on the study.
• Provide written informed consent and willing to comply with protocol requirements.

You may not qualify if:

• Requires any concomitant antineoplastic therapy. Prior chemotherapy should not be administered within 5 half-lives or 28 days whichever is shorter. Subjects on a current stable dose of hormonal treatments may continue on a stable dose during the study (i.e. arimidex, amarosin, herceptin).
• Prior confirmed allergic reaction (including moderate rash, dyspnea, wheezing, urticaria or other symptoms) attributed to the administration of either anthracyclines or other liposomally encapsulated drugs that required discontinuation of prior therapy.
• Prior therapy with anthracyclines exceeding the following doses (subjects will be discontinued at 600 mg/m2 lifetime dose irrespective of the number of ThermoDox® cycles received):
• Free (i.e., non-liposomal) or liposomal doxorubicin \> 450 mg/m2 Free epirubicin \> 900 mg/m2.
• Previous (required active treatment within 5 years) or concomitant malignancy except basal cell cancer, in situ carcinoma of the cervix, or contralateral breast cancer. Subjects with a prior contralateral breast malignancy can be included if they did not receive any chemotherapy.
• Baseline laboratories (repeat labs can be evaluated at baseline to establish eligibility):
• ANC Granulocytes \< 1,500/ microliter
• Platelets \< 75,000/ microliter
• Hemoglobin \< 9 gm/dL
• Total Bilirubin \> 2 mg/dL
• ALT and AST \> 2.5 X upper limit of normal
• Creatinine \> 1.5 X upper limit of normal.
• ECOG/Zubrod Performance Status \> 2.
• MUGA/Echocardiogram Left Ventricular Ejection Fraction \< 50%.
• Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Sponsors & Collaborators

• Imunon: lead

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Southwestern Regional Medical Center

Tulsa, Oklahoma, 74133, United States

Location

Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

Related Publications (1)

• Zagar TM, Vujaskovic Z, Formenti S, Rugo H, Muggia F, O'Connor B, Myerson R, Stauffer P, Hsu IC, Diederich C, Straube W, Boss MK, Boico A, Craciunescu O, Maccarini P, Needham D, Borys N, Blackwell KL, Dewhirst MW. Two phase I dose-escalation/pharmacokinetics studies of low temperature liposomal doxorubicin (LTLD) and mild local hyperthermia in heavily pretreated patients with local regionally recurrent breast cancer. Int J Hyperthermia. 2014 Aug;30(5):285-94. doi: 10.3109/02656736.2014.936049.

  PMID: 25144817 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hot Temperature

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Nicholas Borys, MD

  Imunon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

US (6)