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Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Proxinium
Sponsored by
Sesen Bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

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

Inclusion Criteria: Disease Characteristics: Histologically confirmed recurrent squamous cell carcinoma of the head and neck. Immunohistochemically confirmed epithelial cell adhesion molecule (EpCAM)-positive SCCHN. Must have at least 1 accessible target tumor that is amenable to adequate direct injection. The patient must have at least 1 accessible target tumor without direct carotid artery involvement. Prior/Concurrent Therapy: The patient must have received therapy for their primary disease The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. The patient's disease must be refractory. There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy of at least 12 weeks. Adequate hepatic function ALT and AST and total bilirubin levels ≤1.5 times ULN. Adequate renal function (serum creatinine <2.0 mg/dL). Hematologic values consisting of granulocytes ≥1500/μL, platelets ≥100 000/μL, and hemoglobin >8 g/dL. Prothrombin time and partial thromboplastin time within normal limits Other: The patient must provide written informed consent. Fertile patients must use effective contraception Exclusion Criteria: Brain tumor or brain metastases. Nasopharyngeal SCCHN. Human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen. Uncontrolled bleeding from any target tumor(s) that are being considered for treatment or a history of tumor hemorrhage that has required medical intervention (other than direct compression). The patient is a candidate for surgical tumor resection of their target tumor(s). Pregnant or lactating. Clinically significant renal or hepatic disease. Requires regular use of aspirin, full-dose warfarin, or heparin.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Arkansas for Medical Sciences
  • UCLA Medical Center
  • John P. Thropay, MD
  • Mile High Oncology
  • M.D. Anderson Cancer Center Orlando
  • Evanston Northwestern Healthcare
  • Ingalls Memorial Hospital
  • University of Kansas Medical Center
  • LSU Health Sciences Center
  • Dana Farber Cancer Institute
  • Dartmouth-Hitchcock Medical Center
  • University of Oklahoma Health Sciences Center
  • Portland VA Medical Center
  • Hospital of the University of Pennsylvania
  • Medical University of South Carolina
  • Mary Crowley Medical Research Center
  • Princess Margaret Hospital
  • CHUQ, L'Hotel-Dieu de Quebec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Determination

Arm Description

The recommended dose (RD) for Proxinium is to be determined based on the rate of Dose Limiting Toxicities (DLT) within each dose cohort. The RD is to be established as the highest dose at which one or fewer patients out of six within a dose cohort experienced a DLT. The initial dose level is 500 μg of Proxinium in PBS (the amount of PBS used will be based on the estimated volume of the target tumour). Doses are to be escalated to a maximum of 700 μg or de-escalated to a minimum of 260 μg according to the prescribed algorithm outlined in the study protocol.

Outcomes

Primary Outcome Measures

To determine the safety, tolerability and recommended dose (RD) of Proxinium

Secondary Outcome Measures

Full Information

First Posted
January 3, 2006
Last Updated
December 22, 2015
Sponsor
Sesen Bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00272181
Brief Title
Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer
Official Title
A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Proxinium in Patients With Advanced SCCHN Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual in North America
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sesen Bio, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the safety, effectiveness, and recommended dose of Proxinium in North American patients with Squamous Cell Head and Neck Cancer
Detailed Description
This study was an open-label, multicentre, dose determination study evaluating the safety and tolerability of Proxinium in the treatment of patients with advanced SCCHN who had received at least one anti-cancer treatment regimen for advanced disease. Fifteen patients were enrolled at nine sites. All patients with histologically confirmed SCCHN who had advanced disease were considered potential candidates for study entry. Patients completed two phases of screening termed Initial Screening and Final Screening. Initial Screening assessed the EpCAM status of the patient's SCCHN prior to final screening procedures taking place. Patients had to have a biopsy of their advanced disease that had been appropriately collected for verification of EpCAM-positive SCCHN by immunohistochemical methods. If EpCAM-positive SCCHN was confirmed, the patient could enter Final Screening to determine full eligibility for participation in the study. At the beginning of Final Screening, all patients had to have received at least one anti-cancer treatment regimen for advanced disease. Patients who had successfully completed both Initial and Final Screening had a Principal Target Tumour and up to five additional Target Tumours designated for treatment prior to Day 1 dosing. Only one target tumour per week was to be injected. The Investigator was to treat the principal target tumour until clinically relevant tumour control of the principal target tumour was achieved, at which point other target tumours could be chosen and injected once per week at the same dose level of Proxinium. The study was to comprise two stages. In Stage I, the recommended dose (RD) for Proxinium was to be determined based on the rate of dose-limiting toxicities (DLTs) within each dose cohort. A DLT was defined as the occurrence of excessive toxicity during the first four weeks of each patient's treatment with Proxinium during Stage I of the study, before the RD had been determined. The RD was to be established as the highest dose at which one or fewer patients out of six within a dose cohort experienced a DLT. The initial dose level was to be 500 µg, and three patients were to be initially enrolled into this dose cohort. Doses were to be escalated to a maximum of 700 µg or de-escalated to a minimum of 260 µg according to the prescribed algorithm outlined in the study protocol and based on the number of patients experiencing a DLT within each dose cohort. Safety data was to be reviewed by the medical monitor, the site investigators who had enrolled patients at that dose, and Viventia Biotech Inc. (the sponsor) to determine if escalation or de-escalation was to occur. All Stage I patients, including those in the original RD cohort, were to remain in Stage I and continue treatment beyond their initial four weeks at their original dose assignment. If dose de-escalation was deemed necessary, all Investigators with patients receiving higher doses would have been notified and given the option of either administering a de-escalated dose or discontinuing treatment. Stage II was to commence once the RD had been determined and an independent third party had reviewed the safety data. Patients enrolled subsequently were to receive treatment at the RD. The RD cohort was to be expanded to include a total of 15 patients, and safety and efficacy evaluation was to continue being assessed. Continued safety and tolerability as well as response rates, therapeutic endpoints, survival time, PK parameters, and immunogenicity were evaluated. Regardless of dose cohort, all patients were to be treated until complete resolution of all accessible Target Tumours, clinically relevant tumour progression, or until study drug suspension or withdrawal criteria had been met. Four weeks after the end-of-treatment visit, patients were to return to the site for a follow-up visit that was to include a CT scan of the head and neck as well as other assessments, as described in the study protocol. Subsequently, patients were to enter the post-study surveillance period. Enrolment in the study was halted before the RD of Proxinium was determined, and hence, Stage II of this study was not conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck, Carcinoma, Squamous Cell, Neoplasms, Squamous Cell, Head and Neck Neoplasms, Mouth Neoplasms, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Determination
Arm Type
Experimental
Arm Description
The recommended dose (RD) for Proxinium is to be determined based on the rate of Dose Limiting Toxicities (DLT) within each dose cohort. The RD is to be established as the highest dose at which one or fewer patients out of six within a dose cohort experienced a DLT. The initial dose level is 500 μg of Proxinium in PBS (the amount of PBS used will be based on the estimated volume of the target tumour). Doses are to be escalated to a maximum of 700 μg or de-escalated to a minimum of 260 μg according to the prescribed algorithm outlined in the study protocol.
Intervention Type
Drug
Intervention Name(s)
Proxinium
Intervention Description
Intratumoral administration of Proxinium directly to target tumors.
Primary Outcome Measure Information:
Title
To determine the safety, tolerability and recommended dose (RD) of Proxinium
Time Frame
Weekly dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disease Characteristics: Histologically confirmed recurrent squamous cell carcinoma of the head and neck. Immunohistochemically confirmed epithelial cell adhesion molecule (EpCAM)-positive SCCHN. Must have at least 1 accessible target tumor that is amenable to adequate direct injection. The patient must have at least 1 accessible target tumor without direct carotid artery involvement. Prior/Concurrent Therapy: The patient must have received therapy for their primary disease The patient must have been diagnosed with persistent or recurrent disease or a second primary tumour. The patient's disease must be refractory. There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy and receiving study drug or 4 weeks between the last dose of an experimental drug and receiving study drug. Patient Characteristics: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy of at least 12 weeks. Adequate hepatic function ALT and AST and total bilirubin levels ≤1.5 times ULN. Adequate renal function (serum creatinine <2.0 mg/dL). Hematologic values consisting of granulocytes ≥1500/μL, platelets ≥100 000/μL, and hemoglobin >8 g/dL. Prothrombin time and partial thromboplastin time within normal limits Other: The patient must provide written informed consent. Fertile patients must use effective contraception Exclusion Criteria: Brain tumor or brain metastases. Nasopharyngeal SCCHN. Human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen. Uncontrolled bleeding from any target tumor(s) that are being considered for treatment or a history of tumor hemorrhage that has required medical intervention (other than direct compression). The patient is a candidate for surgical tumor resection of their target tumor(s). Pregnant or lactating. Clinically significant renal or hepatic disease. Requires regular use of aspirin, full-dose warfarin, or heparin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Cuthbert
Organizational Affiliation
Sesen Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
John P. Thropay, MD
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Mile High Oncology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
M.D. Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUQ, L'Hotel-Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
GIR 5C3
Country
Canada

12. IPD Sharing Statement

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Study of Proxinium for Treating Patients With Squamous Cell Head and Neck Cancer

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