Trial record 1 of 1 for:    NCT01416038
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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
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Biological: DPX-Survivac
Drug: low dose cyclophosphamide (oral)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by ImmunoVaccine Technologies, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: December 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine
Phase 1, Cohort A: 0.5 mL of DPX-Survivac (injection)
Biological: DPX-Survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
Experimental: Vaccine + low dose cyclophosphamide
Phase 1, Cohort B: 0.1 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
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 + low dose cyclophosphamide.
Phase 1, Cohort C: 0.5 mL DPX-Survivac (injection) with low dose cyclophosphamide (oral)
Biological: DPX-Survivac
Vaccine targeting survivin antigen will be administered subcutaneously.
Drug: low dose cyclophosphamide (oral)
Low dose cyclophosphamide will be taken by mouth.

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 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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416038

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
ImmunoVaccine Technologies, Inc.
  More Information

No publications provided

Responsible Party: ImmunoVaccine Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01416038     History of Changes
Other Study ID Numbers: ONC-DPX-Survivac-01
Study First Received: August 9, 2011
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoVaccine Technologies, Inc.:
vaccine
immunotherapy
ovarian
fallopian tube
peritoneal
cancer
tumor
Phase 1
Phase 2
Phase I
Phase II

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal 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
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 30, 2014