Status:
COMPLETED
Phase 1 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
Lead Sponsor:
ImmunoVaccine Technologies, Inc. (IMV Inc.)
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
Immunotherapy is a novel way to treat cancer and does so by targeting the immune system to destroy tumor cells. Many different therapeutic vaccines have been evaluated in phase 1, 2, and even phase 3 ...
Detailed Description
The standard treatment for all ovarian cancer is aggressive debulking surgery followed by chemotherapy. Ovarian carcinoma is one of the most chemosensitive solid tumors and early stage patients are mo...
Eligibility Criteria
Inclusion
- Main
- Subjects with stage IIc-IV epithelial ovarian, fallopian tube and peritoneal cancer who have completed adjuvant treatment consisting of up to 8 cycles of paclitaxel and carboplatin chemotherapy or other acceptable chemotherapy after initial debulking surgery with evidence of a complete or partial response by radiological imaging. These subjects may remain on hormonal therapy during the trial if such treatment has been prescribed by their treating physician. These subjects may have been in a clinical trial for an investigational carboplatin based adjuvant therapy.
- Subjects with recurrent ovarian, fallopian tube or peritoneal cancer who have clinical or radiologic evidence of a complete or partial response or stable disease after completion of first-line chemotherapy for their recurrent disease and are not suitable for additional cytotoxic therapy are eligible. These subjects may have previously received a course of adjuvant chemotherapy earlier in their disease management as described in point one above. These subjects are eligible regardless of their CA-125 results. These subjects may have been in a clinical trial of an investigational therapy.
- Subjects may have received previous courses of an investigational biologic therapy including active or passive immunotherapy greater than 60 days prior to receiving the first injection of DPX-Survivac
- At least 30 days since localized surgery, radiotherapy or chemotherapy
- Subjects may be on a biphosphonate provided it had not been initiated within 14 days prior to receiving the first injection of DPX-Survivac
- Main
Exclusion
- Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are excluded
- Subjects who participated in therapeutic adjuvant ovarian cancer studies are excluded except for platinum-based adjuvant studies
- Subjects who have received more than one course of chemotherapy for recurrent disease
- Subjects receiving bevacizumab for maintenance therapy are excluded (subjects who received bevacizumab as part of their adjuvant therapy will be permitted)
- History of autoimmune disease
- Subjects with recent history of thyroiditis
- Presence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitis
- Subjects with brain metastases
- Concurrent (within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, or controlled bladder cancer
- Acute or chronic skin disorders that will interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions
- Serious intercurrent chronic or acute illness, such as cardiac disease, hepatic disease, or other illness considered by the investigator as an unwarranted high risk for an investigational product
- Subjects on steroid therapy or other immunosuppressive, such as azathioprine or cyclosporin A
- Allergies to any component of the vaccine
- Pregnant or nursing mothers
- Subjects with a medical or psychological impediment to probable compliance with the protocol
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01416038
Start Date
December 1 2011
End Date
May 1 2013
Last Update
April 21 2017
Active Locations (7)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
Winthrop University Hospital
Mineola, New York, United States, 11501
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Oregon Health & Science University
Portland, Oregon, United States, 97239