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| Sponsored by: |
AVAX Technologies |
|---|---|
| Information provided by: | AVAX Technologies |
| ClinicalTrials.gov Identifier: | NCT00660101 |
Purpose
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
|
Show Detailed Description
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 |