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| Descriptive Information Fields | |||||||||
| Brief Title † | Ovarian Dendritic Cell Vaccine Trial | ||||||||
| Official Title † | Defining the Role of CD4+CD25+ Immunoregulatory T-Cells in the Treatment of Patients With Advanced Ovarian Cancer Who Receive Dendritic Cell Based Vaccine Therapies | ||||||||
| Brief Summary | The purpose of this study is to determine if an immune modifying drug (Ontak) alone or as part of a vaccine therapy will produce remissions in patients with advanced ovarian cancer. This research is being done because we want to find new therapies for treatment of relapsed or refractory (resistant to ordinary treatment) ovarian cancer. The use of ONTAK and vaccine therapy is research. A new experimental approach for treating refractory or relapsed ovarian cancer involves using the patients own immune system to kill the cancer cells. These immune cells are called monocytes and are harvested from blood. The process of Leukapheresis collects the monocytes called Dendritic Cells. This is usually a 3 hour process done in the comfort of a hospital bed in the apheresis lab, similar to giving blood for donation. Approximately 300cc's are collected during this process, the equivalent of about 10 ounces of blood. Once these dendritic cells are collected - a special laboratory grows and processes them into a vaccine using a patient's own tumor cells. This preparation is then given back to the patient hopefully to stimulate the immune system to kill cancer cells. This type of treatment is considered biological research. This study also involves a drug called ONTAK, which is made using certain proteins from diphtheria toxins and interleukin-2 (chemotherapy drug). This drug will act on immune suppressing cells normally present in your body making vaccine therapy possibly less effective. Ontak helps set up your immune system to be boosted by the vaccine injections. The use of Ontak followed by the vaccine to stimulate your tumor killing immune cells has not been done in ovarian cancer before and is research. |
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| Detailed Description | Patients with advanced ovarian carcinoma who have failed initial curative chemotherapy attempts will be evaluated at the time of relapse for tumor debulking surgery prior to the initiation of salvage chemotherapy. If appropriate, samples will be collected for tumor lysate preparation for vaccination as per the existing Loyola protocol. Lysates may also be produced by the collection of malignant effusions as performed for palliation of symptoms. Patients will then receive palliative chemotherapy to a maximum tumor cytoreduction. Patients from whom sufficient tumor cells have been collected for DC-based vaccine production will undergo a leukapheresis for DC cell production. Once completed, these patients will be randomly assigned one of two treatment groups: Cohort (Group) 1 - Administration of a single dose of Ontak at 18 μg/kg followed by DC vaccination with 1 x 106 tumor lysate and KLH-loaded immature DCs into inguinal nodes identified by ultrasound guidance for a total of three injections at two week intervals; or Cohort (Group) 2 - Identical DC vaccination as in Group 1 without Ontak pre-treatment. Patients for whom collection of tumor cells for lysate preparation is not possible will be assigned to Cohort (Group) 3, with administration of Ontak at the same dose without vaccination. In this pilot study we plan to treat 12 patients in each group over a two-year period of time. Therapy will begin four weeks after chemotherapy completion, given to achieve maximum cytoreduction prior to protocol therapy initiation |
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| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | To determine if immunoregulatory T-cell inhibition by Ontak followed by the administration of an autologous tumor lysate-loaded dendritic cell vaccine enhances the immune response in patients with relapsed/refractory ovarian cancer [ Time Frame: days 45 and 62 post vaccine ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | To define the in vitro and in vivo responses of Ontak with and without DC vaccination. [ Time Frame: Days 46 and 62 post vaccine ] [ Designated as safety issue: No ] To characterize the toxicities of this novel Treg/DC-based vaccination strategy. [ Time Frame: weekly assessments for a total of 4 weeks ] [ Designated as safety issue: Yes ] |
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| Condition † | Ovarian Cancer | ||||||||
| Intervention † | Biological: Ontak DC Biological: DC vaccination Drug: Ontak |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 36 | ||||||||
| Start Date † | October 2008 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Additional eligibility requirements for vaccine therapy initiation:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00703105 | ||||||||
| Organization ID | 200541 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Loyola University | ||||||||
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| Information Provided By | Loyola University | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | June 19, 2008 | ||||||||
| Last Updated Date | October 22, 2008 | ||||||||