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| Sponsor: | AVAX Technologies |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
Other Names:
|
|
Experimental: 2
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
Other Names:
|
|
Experimental: 3
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
Other Names:
|
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: Julio D Doligosa 847-872-4019 julio.doligosa@ctca-hope.com | |
| Principal Investigator: Sybilann Williams, MD | |
| United States, Oklahoma | |
| Cancer Treatment Centers of America (CTCA-Southwestern) | Recruiting |
| Tulsa, Oklahoma, United States, 74133 | |
| Contact: JJ Hale, BS,CCRC 918-286-5449 JJ.hale@ctca-hope.com | |
| Principal Investigator: Theodore Pollock, D.O. | |
| United States, Pennsylvania | |
| Cancer Treatment Centers of America (ERMC) | Recruiting |
| Philadelphia, Pennsylvania, United States, 19124 | |
| Contact: Marty Weinar, MS, RN, CAGS 215-537-7569 marty.weinar@ctca-hope.com | |
| Principal Investigator: David Berd, MD | |
| Study Director: | Henry E Schea | AVAX Technologies |
More Information
| Responsible Party: | AVAX Technologies |
| ClinicalTrials.gov Identifier: | NCT00660101 History of Changes |
| Other Study ID Numbers: | A/100/0501 |
| Study First Received: | April 16, 2008 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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ovarian cancer vaccine immunotherapy autologous |
|
Adenocarcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Carcinoma Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |