Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
AVAX Technologies |
---|---|
Information provided by: | AVAX Technologies |
ClinicalTrials.gov Identifier: | NCT00660101 |
To determine if a vaccine made from the patient's own tumor tissue can stimulate an immune response against the patient's tumor cells. To determine the safety of the vaccine.
Condition | Intervention | Phase |
---|---|---|
Adenocarcinoma of the Ovary |
Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | OVax®: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse: A Feasibility Study Using a DNP-Modified Autologous Ovarian Tumor Cell Vaccine as Therapy in Ovarian Cancer Patients After Relapse |
Estimated Enrollment: | 42 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
5 million autologous, DNP-modified ovarian cancer cells
|
Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
|
2: Experimental
2.5 million autologous, DNP-modified ovarian cancer cells
|
Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
|
3: Experimental
0.5 million autologous, DNP-modified ovarian cancer cells
|
Biological: OVax: Autologous, DNP-Modified Ovarian Cancer Vaccine
Autologous, DNP-modified ovarian cancer cells in suspension dosage - depends on arm route - intradermal frequency - weekly x7, booster at 6 months
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening Phase
Treatment Phase
Exclusion Criteria:
United States, Illinois | |
Cancer Treatment Centers of America (CTCA-Midwestern) | Recruiting |
Zion, Illinois, United States, 60099 | |
Contact: Joy Jardinico, RN 847-731-4143 joy-jardinico@ctca-hope.com | |
Principal Investigator: Sybilann Williams, MD |
Study Director: | Francois Martelet, MD | AVAX Technologies |
Responsible Party: | AVAX Technologies ( Francois Martelet, MD - Chief Executive Officere ) |
Study ID Numbers: | A/100/0501 |
Study First Received: | April 16, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00660101 History of Changes |
Health Authority: | United States: Food and Drug Administration |
ovarian cancer vaccine immunotherapy autologous |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Carcinoma |
Genital Diseases, Female Ovarian Cancer Endocrinopathy Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Ovarian Neoplasms Neoplasms by Histologic Type Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Carcinoma |
Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |