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| Sponsor: | Beth Israel Deaconess Medical Center |
|---|---|
| Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | David Avigan, MD, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00799110 |
Purpose
This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer |
Drug: GM-CSF Biological: Dendritic Cell/Tumor Fusion Vaccine Drug: imiquimod |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod |
| Estimated Enrollment: | 23 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 2
Vaccine, GM-CSF and imiquimod,
|
Drug: GM-CSF
Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Biological: Dendritic Cell/Tumor Fusion Vaccine
Given subcutaneously once every three weeks for a total of three vaccines
Other Name: DC/tumor fusion vaccine
Drug: imiquimod
Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection
|
|
Experimental: Group 1
Vaccination plus GM-CSF
|
Drug: GM-CSF
Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards
Biological: Dendritic Cell/Tumor Fusion Vaccine
Given subcutaneously once every three weeks for a total of three vaccines
Other Name: DC/tumor fusion vaccine
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria at time of initial enrollment:
Eligibility criteria prior to first vaccination
At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill the following criteria:
Asymptomatic, low volume disease not requiring further chemotherapy prior to initiating vaccination
** Complete clinical response is defined as normal exam, normal CT scan, and normal CA-125 level. Tumor tissue for relapsed patients would be obtained under informed consent at the time of a secondary surgical debulking, which would be performed as part of standard relapse management in appropriate patients.
Exclusion Criteria:
Contacts and Locations| Contact: David Avigan, MD | 617-667-9920 | davigan@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: David Avigan, MD 617-667-9920 davigan@bidmc.harvard.edu | |
| Principal Investigator: David Avigan, MD | |
| Sub-Investigator: Jacalyn Rosenblatt, MD | |
| Sub-Investigator: Lynne Uhl, MD | |
| Sub-Investigator: Stephen Cannistra, MD | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Ursula Matulonis, MD 617-632-2334 umatulonis@partners.org | |
| Principal Investigator: Ursula Matulonis, MD | |
| Sub-Investigator: Donald Kufe, MD | |
| Sub-Investigator: Susan Berlin, MD | |
| Sub-Investigator: Susana Campos, MD | |
| Sub-Investigator: Marcus Butler, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Carolyn Krasner, MD 617-726-1941 pdicicco@partners.org | |
| Principal Investigator: Carolyn Krasner, MD | |
| Sub-Investigator: Richard Penson, MD | |
| Sub-Investigator: Marcela Del Carmen, MD | |
| Sub-Investigator: AK Goodman, MD | |
| Brigham & Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Ross Berkowitz, MD 617-732-8843 rberkowitz@partners.org | |
| Sub-Investigator: Ross Berkowitz, MD | |
| Sub-Investigator: Neil Horowitz, MD | |
| Sub-Investigator: Michael Muto, MD | |
| Sub-Investigator: Colleen Feltmate, MD | |
| Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
More Information
| Responsible Party: | David Avigan, MD, Principal Investigator, Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00799110 History of Changes |
| Other Study ID Numbers: | 07-380 |
| Study First Received: | November 26, 2008 |
| Last Updated: | October 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
dendritic cells fusion vaccines GM-CSF imiquimod |
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Imiquimod Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers |