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Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Trial Information

Phase 1-2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide in Patients With Surgically Operable or Advanced Stage Ovarian, Fallopian Tube or Peritoneal Cancer

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 most responsive to treatment. However, despite improvements to the
standard treatment over the past three decades, almost all patients with advanced stage
disease at presentation will relapse, with an average progression free survival of 16-18
months. When residual or recurrent disease manifests itself, resistance to chemotherapy
often prohibits further curative therapy. Therefore, there are still significant unmet needs
in treating ovarian cancer patients.

Treatment with DPX-Survivac is for patients with late-stage ovarian, fallopian tube, or
peritoneal cancer who have completed initial chemotherapy treatment and successful debulking
surgery. The phase 1 dose finding study will administer 3 doses of DPX-Survivac with or
without accompanying low dose oral cyclophosphamide. The phase 2, placebo controlled, study
will administer DPX-Survivac or placebo with accompanying low dose cyclophosphamide or


- non-randomized, open-label, dose-finding study

- at least 15 subjects

- three safety cohorts (listed in the table above)

- safety and immunogenicity findings will determine dosage for phase 2


- 2:1 randomized, double-blinded, placebo controlled study

- approximately 250 subjects

- two arms (1) Experimental: DPX-Survivac (injection) and low dose cyclophosphamide
(oral) and (2) Control: placebo injection and oral placebo

Inclusion Criteria

Main Inclusion Criteria for Phase 1:

- 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 Criteria for Phase 1:

- Subjects undergoing concurrent chemotherapy, radiation therapy, immunotherapy are

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PHASE 1: Number of reported adverse events

Outcome Description:

The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of subcutaneous administration of DPX-Survivac.

Outcome Time Frame:

Until 6 month follow up

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • vaccine
  • immunotherapy
  • ovarian
  • fallopian tube
  • peritoneal
  • cancer
  • tumor
  • Phase 1
  • Phase 2
  • Phase I
  • Phase II
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Winthrop University Hospital Mineola, New York  11501
Oregon Health & Science University Portland, Oregon  97201
Duke University Medical Center Durham, North Carolina  27710
Mary Crowley Cancer Research Center Dallas, Texas  75246