Phase 1b Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/8/2017
Start Date:August 23, 2013
End Date:November 30, 2017

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Phase 1b Study of Extended Dosing of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer.

As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of
immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The
combination treatment is being evaluated in a non-randomized, multi-cohort study as
post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or
peritoneal cancer.


Key Inclusion Criteria:

- Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal
cancer

- Complete or partial response following standard of care surgery and first line
chemotherapy

- May have one disease recurrence with complete or partial response or stable disease
following standard of care second line care treatment

- Previous investigational biologic therapy allowed, must be more than 56 days prior to
first injection

- Previous treatment with bisphosphonate allowed, must be completed 14 days prior to
first injection

- Ambulatory with an ECOG 0-1

- Life expectancy > 6 months

- Meet protocol-specified lab requirements

- Provide informed consent and have ability to comply with protocol requirements

Key Exclusion Criteria:

- Concurrent chemotherapy, radiation therapy, immunotherapy are excluded (washout
periods as specified in protocol)

- Prior receipt of survivin based vaccines

- Participation in prior therapeutic adjuvant ovarian cancer studies, except for
platinum-based adjuvant studies

- Progressive disease (rising CA-125 acceptable)

- More than one course of chemotherapy for recurrent disease

- Concurrent bevacizumab as maintenance therapy

- Concurrent second malignancy other than non-melanoma skin cancer, cervical carcinoma
in situ, or controlled bladder cancer

- History of autoimmune disease

- Recent history of thyroiditis

- Presence of a serious acute infection or chronic infection

- Brain metastases

- Other serious intercurrent chronic or acute illness

- Ongoing treatment with steroid therapy or other immunosuppressive

- Acute or chronic skin disorders
We found this trial at
3
sites
New York, New York 10021
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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