Phase 1-2 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ImmunoVaccine Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01416038
First received: August 9, 2011
Last updated: January 16, 2013
Last verified: January 2013

August 9, 2011
January 16, 2013
December 2011
April 2013   (final data collection date for primary outcome measure)
  • PHASE 1: Number of reported adverse events [ Time Frame: Until 6 month follow up ] [ Designated as safety issue: Yes ]
    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.
  • PHASE 2: Progression free survival as per RECIST 1.1 criteria [ Time Frame: Until last progression-free patient is 1.5 years beyond first vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01416038 on ClinicalTrials.gov Archive Site
  • PHASE 1-2: Levels of cell mediated immunity targeting the survivin epitopes [ Time Frame: Until 6 month follow up ] [ Designated as safety issue: No ]
  • PHASE 2: Repeated CA-125 measurements [ Time Frame: Until last progression-free patient is 1.5 years beyond first vaccination ] [ Designated as safety issue: No ]
    Comparison of the effects on tumor control by vaccine versus placebo treatment.
  • PHASE 2: Progression free survival as per immune response criteria (irRC) [ Time Frame: Until last progression-free patient is 1.5 years beyond first vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase 1-2 Study of a Cancer Vaccine to Treat Patients With Advanced Stage Ovarian, Fallopian or Peritoneal Cancer
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

This is a phase 1-2 study to determine the safety and immunogenicity profiles of DPX-Survivac, a therapeutic vaccine co-administered with a regimen of low dose oral cyclophosphamide. DPX-Survivac is for the treatment of ovarian, fallopian tube, and peritoneal cancers.

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 trials. Much has been learned about the principles of applying immune-based therapies and specifically the types of patients that may be most likely to mount an effective immune response. Cancer vaccines may have their greatest impact earlier in the disease course or in situations with minimal residual disease.

ImmunoVaccine Technologies Inc. (Immunovaccine) is developing therapeutic vaccines against various solid cancers based on a patented vaccine delivery and enhancement system. Immunovaccine's vaccine formulation, termed DepoVax, is a lipid-based formulation created to enhance the speed, strength and duration of the immune response. Immunovaccine's hypothesis is that the immune enhancement properties of its formulation are the result of the co-delivery of antigen and adjuvant and the created depot effect. The peptide antigens included in DPX-Survivac are designed to target Survivin, a protein which is over-expressed in many cancer types, including epithelial ovarian cancers.

This study will begin with a phase 1 safety cohort study; at least 15 non-randomized patients will be enrolled into the open-label dose finding study. The study will then progress directly into the 2:1 randomized, double-blinded phase 2 portion of the study. The phase 2 will be a placebo controlled efficacy study, enrolling approximately 250 patients.

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 placebo.

PHASE 1

  • 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

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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Biological: DPX-Survivac
    Vaccine targeting survivin antigen will be administered subcutaneously.
  • Drug: low dose cyclophosphamide (oral)
    Low dose cyclophosphamide will be taken by mouth.
  • Experimental: Vaccine
    Phase 1, Cohort A: 0.5 mL of DPX-Survivac (injection)
    Intervention: Biological: DPX-Survivac
  • Experimental: Vaccine + low dose cyclophosphamide
    Phase 1, Cohort B: 0.1 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
    Interventions:
    • Biological: DPX-Survivac
    • Drug: low dose cyclophosphamide (oral)
  • Experimental: Vaccine + low dose cyclophosphamide.
    Phase 1, Cohort C: 0.5 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
    Interventions:
    • Biological: DPX-Survivac
    • Drug: low dose cyclophosphamide (oral)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
Not Provided
April 2013   (final data collection date for primary outcome measure)

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 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01416038
ONC-DPX-Survivac-01
Yes
ImmunoVaccine Technologies, Inc.
ImmunoVaccine Technologies, Inc.
Not Provided
Not Provided
ImmunoVaccine Technologies, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP