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Clinical Trial Patient Inquiries

Thank you for your inquiry regarding OXiGENE’s ongoing clinical trial programs. OXiGENE is committed to developing life-extending and -enhancing therapeutics.

The following is a list of our ongoing clinical trials. To learn about enrollment criteria and who to contact for further information about each trial, please click on the links provided. If you think that you meet the criteria shown, please contact the appropriate study center (contact information provided below) for further information. Other than by participating in a clinical trial, patients cannot receive ZYBRESTAT (Combretastatin / CA4P) or other OXiGENE investigational compounds.

If you are interested in general information about the drug development process, our corporate 10K filing with the SEC contains a short description of it. You may view that document online, or contact us and we will send you a hard copy.

Oncology

Ophthalmology

There are currently no ongoing ophthalmology trials.


Ongoing Oncology Trials

ZYBRESTAT (combretastatin / CA4P) Phase II/III in Anaplastic Thyroid Cancer 

A Multicenter, Open-Label, Randomized, Phase II/III Study to Evaluate the Safety and Efficacy of Combretastatin A-4 Phosphate in Combination with Paclitaxel and Carboplatin in Comparison with
Paclitaxel and Carboplatin Against Anaplastic Thyroid Carcinoma

This is an international, multi-center, open-label randomized trial for patients with regionally-advanced or metastatic anaplastic thyroid cancer. Approximately 180 patients will enrolled at sites in the United States, Europe and India. All participants will receive standard chemotherapy with carboplatin and paclitaxel. Enrolled patients will be randomized on a 2:1 basis to the treatment arm (ZYBRESTAT plus carboplatin and paclixael) or the control arm (carboplatin and paclitaxel).  This means that 2/3 of participants will receive the investigational product in combination with chemotherapy and 1/3 will receive chemotherapy alone.

Select Entry Criteria
In order to participate in the study, you must:

1. Be 18 years of age or older.
   
   
2. Have anaplastic thyroid carcinoma diagnosed from a biopsy (for physicians, this means histologically or cytologically confirmed by a pathology review).
   
   
3. Be strong enough to be able to walk, take care of your basic personal needs (such as dressing, toileting), and to be out of bed at least half your waking hours (for physicians, this means ECOG Performance Score ≤ 2).
   
   
4. Be expected to live at least 12 weeks.
   

There are restrictions related to other therapies that you may have received for treatment of thyroid cancer, which include:

1. You may have received only one chemotherapy regimen for metastatic cancer, though this may consist of a combination of different types of treatment.
   
   
2. You may not have received another chemotherapy drug for 3 weeks before receiving treatment in the study.
   
   
3. You may not have had radiation for 4 weeks before receiving treatment in the study

For more information about the thyroid cancer clinical trial, including more detailed study entry criteria, please see or contact:

www.ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT00507429)

ThyCa: Thyroid Cancer Survivors’ Association, Inc. 
Website: www.thyca.org
Toll free number: 1-877-588-7904
Email address: thyca@thyca.org

Cancer Prevention and Control Center at West Virginia University  
Toll free number: 866-927-5656
International number: (304) 293-8726
Email address: ATCtrial@hsc.wvu.edu


Study Sites- United States

Jame Abraham, M.D.
West Virginia University Hospital
West Virginia University
Morgantown, WV 26506

Phone: 304-293-1683
*****
Frank Ondrey, M.D.
University of Minnesota
Otolaryngology Department
Lions Research Building, 2001  6th Street SE, Rm. 270 LRB
Minneapolis, MN  55455

Study Coordinator:  Kate Cole
colex006@umn.edu
Phone: 612-625-5602
Fax: 612-624-7959
*****
Dr. Julie Ann Sosa
Yale University, School of Medicine
Surgery
333 Cedar Street, TMP 204, P.O. Box 208062
New Haven, CT  06520  

Study Coordinator: Jennifer Seeley
jennifer.seeley@yale.edu
phone 203-737-5083 fax: 203-785-6781
*****
Dr. Michael Heinrich
Oregon Health and Science University
Hematology and Oncology
3181 SW Sam Jackson Park Road, Mail Code L586
Portland, OR  97239  

Study Coordinator: Erin Neal
neale@ohsu.edu
phone: 503-494-7702
fax: 503-494-3224
*****

Dr. Barbara Gitlitz
USC – Norris Comprehensive Cancer Hospital
Oncology
1441 East Lake Avenue, Room 3452
Los Angeles, CA 92233
Email: Gitlitz@usc.edu

Study Coordinator
Gina Tse
Phone: 323-865-3962
*****
Dr. Bryan Haugen
University of Colorado Cancer Center
Clinical Investigation Core
1665 North Ursula Street, Room 3200
P.O. Box 6510 Mailstop F704
Aurora, CO 97239
Email:bryan.haugen@uchsc.edu

Study Coordinator
Brittany Hines
Phone: 720-724-3921
*****
Dr. Fadlo R. Khuri
Winship Cancer Institute
Emory University
Hematology/Oncology
1365-C Clifton Road, NE
Atlanta, GA 30322
Email: fkhuri@emory.edu

Study Coordinator
Austin Hamilton
Phone: 404-778-4250

*****

Study Sites - India

Chandrasekhar Bal, M.D.
All India Institute of Medical Sciences
Department of Nuclear Medicine Therapy, Room Number 57
AIIMS, Ansari Nagar
New Delhi, Delhi 110029
*****
M. Vidyasagar, M.D.
Department of Radiotherapy and Oncology
Shirdi Sai Baba Cancer Hospital
K.Katsurba Medical College & Hospital
Manipal, Karnataka 576119
*****
Dr. Sameer Kaul
Apollo Cancer Institute
Spectra Clinical Research Centre
Indraprastha Apollo Hospital, Sarita Vihar
Delhi Mathura Road, New Delhi 110076
 
Study Coordinator: Dr. Alok Miglani
0091-1126925825
*****

Study Sites - Israel

Rami Ben-Yosef, M.D.
Telaviv Sourasky Medical Center, Head and Neck Service Division of Oncology
Tel-Aviv, Israel
Rinat Lectman
Phone: 972 3 697 4833
Email:  ramiby@post.tau.ac.il
*****

Study Sites - United Kingdom

Dr. Nicholas Simon Reed
Beatson Oncology Centre
Gartnaval General Hopsital
1053 Great Western Road
Scotland,  UK G12 0YN
Email: nick.reed@northglasgow.scot.nhs.uk

Study Coordinator
Gemma Tait
Phone:  44 1413017055

*****

_____

ZYBRESTAT (Combretastatin / CA4P) Phase Ib in Advanced Non-small Cell Lung Cancer, Head, Neck, or Prostate Cancer  

A Phase Ib Trial of CA4P in Combination with Radiotherapy in Patients with Advanced Non-small Cell Lung Cancer, Head and Neck, or Prostate

This is a single center open-label study being conducted in the United Kingdom.  Approximately 40 patients with primary cancer of the lung, head and neck, or prostate will be enrolled. All participants will receive Zyberstat.  

Selected Entry Criteria
In order to participate in the study, you must:

1. Be 18 years of age or older.

2. Have non-small cell lung cancer, squamous head and neck cancer or prostatic adenocarcinoma diagnosed from a biopsy.

3. Be unable to undergo external beam radiotherapy.

4. Be strong enough to be able to walk, take care of your basic personal needs (such as dressing, toileting), and to be out of bed at least half your waking hours (for physicians, this means ECOG Performance Score ≤ 2)

5. Have adequate function of liver and kidney.

6. Have an adequate blood count.

At least four weeks must have passed since your last chemotherapy, immunotherapy or radiotherapy.

Patients with brain metastasis may not participate.  

Clinical Center

Peter Hoskin, M.D.
Mount Vernon Hospital
Northwood, Middlesex
UNITED KINGDOM
Phone: +44 1923 844 533

_____

ZYBRESTAT (Combretastatin / CA4P) Phase II in Advanced Platinum-Resistant Ovarian Cancer

A Phase II Trial of CA4P in Combination with Carboplatin and Paclitaxel Chemotherapy in Patients with Advanced Platinum-Resistant Ovarian Cancer

This study is being conducted at six centers in the United Kingdom.  The study will enroll approximately 43 patients with advanced platinum-resistant ovarian or closely related cancers (specifically primary peritoneal or fallopian tube cancer) who have relapsed within six months following first-line treatment with a platinum-containing chemotherapy regimen. All participants will receive ZYBRESTAT, carboplatin and paclitaxel.

This study is designed as a two-stage study, in which a pre-specified efficacy criterion must be achieved in the first stage of the study in order for the study to progress and continue to enroll patients in the second stage.  On December 31, 2007, OXiGENE reported that the study had achieved this pre-specified efficacy criterion and would progress to the second stage and enroll further patients.  (See the press releases section of this website for further information.)

Selected Entry Criteria:
In order to participate in the study, you must:

1. Be 18 years of age or older.
2. Have advanced ovarian, fallopian tube or primary peritoneal cancer already treated with a chemotherapy regimen that included cisplatin or carboplatin.
3. Be strong enough to be able to walk, take care of your basic personal needs (such as dressing, toileting), and to be out of bed at least half your waking hours (for physicians, this means ECOGPerformance Score ≤ 2).
4. Have adequate function of liver and kidneys.
5. Have an adequate blood count.

At least four weeks must have elapsed since your last chemotherapy, immunotherapy or radiotherapy.

Patients with brain metastasis may not participate. 

Clinical Centers

Gordon Rustin, M.D.
Mount Vernon Hospital
Northwood, Middlesex
UNITED KINGDOM
Phone: +44 1923 844 190

Bass Hassan, M.D.
Oxford Radcliffe Hospitals
Headington, Oxford
UNITED KINGDOM
Phone: +44 1865 226 190

Gordon Jayson, M.D.
Christie Hospital
Withington, Manchester
UNITED KINGDOM
Phone: +44 1614 463 606

Richard Osborne, M.D.
Poole Hospital
Poole, Dorset
UNITED KINGDOM
Phone: +44 1202 448 265

Nick Reed, M.D.
Beatson Oncology Centre
Western Infirmary
Glangous
UNITED KINGDOM
Phone: +44 1412 111 764

David Parkin, M.D.
Aberdeen Royal Infirmary
Aberdeen
UNITED KINGDOM
Phone: +44 1224 551 283

_____

ZYBRESTAT (Combrestatin / CA4P) Phase I in Advanced Solid Tumors in Combination with Avastin 

A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Combretastatin A4 Phosphate Given in Combination with Bevacizumab to Subjects with Advanced Solid Tumors

This study is being conducted at two sites in the United Kingdom. The study will enroll approximately 40 patients with advanced solid tumors that have progressed on standard therapy. All participants will receive combination therapy with ZYBRESTAT and Avastin (bevacizumab).

Selected Entry Criteria
In order to participate in the study, you must:

1. Be 18 years of age or older.

2. Have solid tumor shown to be a malignant cancer on biopsy.

3. Have failed standard therapy or for which no life prolonging treatment exists.\

4. Be strong enough to be able to walk, take care of your basic personal needs (such as dressing, toileting), and to be out of bed at least half your waking hours (for physicians, this means ECOG Performance Score ≤ 2).\

5. Have adequate function of liver and kidneys.

6. Have an adequate blood count.

At least four weeks must have elapsed since your last chemotherapy, immunotherapy or radiotherapy. You may not have previously received Avastin (bevacizumab).

Patients with brain metastasis may not participate.  

Clinical Centers

Paul Nathan, M.D.
Mount Vernon Hospital
Northwood, Middlesex
UNITED KINGDOM

Ian Judson, M.D.
Royal Marsden Hospital
Sutton, Surrey

_____

ZYBRESTAT (combretastatin / CA4P) Phase II in Combination with Carboplatin, Paclitaxel and Bevacizumab in Patients with Chemotherapy-Naïve, Stage IIIB/IV Non-small Cell Lung Cancer

A Phase II Study to Assess the Safety and Efficacy of the Combination of Carboplatin, Paclitaxel and Bevacizumab ± Combretastatin A4 Phosphate (CA4P) Followed by Bevacizumab ± CA4P in Subjects With Chemotherapy Naïve Stage IIIB/IV Non-Squamous Cell Histology Non-Small Cell Lung Cancer (NSCLC)

For further information on this study, including entry criteria and clinical trial sites, please see www.ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT00653939).

_____

OXi4503 Phase I in Advanced Solid Tumors

A Phase I Trial of OXi4503 (an ortho-quinone prodrug) in Patients with Advanced Solid Tumors

This is a dose-escalating Phase I study evaluating the safety of OXi4503 (Combretastatin A-1 Phosphate) administered to patients with advanced solid tumors. Approximately 18 to 40 patients will be required to complete this study. All participants will receive OXi4503, at varying dose levels.

Selected Entry Criteria
In order to participate in the study, you must:

1. Be 18 years of age or older.

2. Have a solid tumor shown to be a malignant cancer on a biopsy.

3. Have received standard treatment without cure, or have a type of cancer for which there is not standard treatment.

4. WHO performance status of 0 or 1.

Clinical Centers

The Information Nurses
Cancer Research UK
PO Box 123
61, Lincoln's Inn Fields
London
UNITED KINGDOM
Phone: +44 207 061 8355

Paul Nathan, M.D.
Mount Vernon Hospital
Northwood, Middlesex
UNITED KINGDOM

Ian Judson, M.D.
Royal Marsden Hospital
Sutton, Surrey
UNITED KINGDOM

Chris Joyce
Senior Director of Clinical Affairs
OXiGENE, Inc.
781-547-5900
oxigeneclinical@oxigene.com

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