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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-23

Study Completion Date

2019-09-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type BIOLOGICAL

SubQ injection

Cyclophosphamide

Intervention Type DRUG

PO BID

Interventions

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DPX-Survivac

SubQ injection

Intervention Type BIOLOGICAL

DPX-Survivac(Aqueous)

SubQ injection

Intervention Type BIOLOGICAL

Cyclophosphamide

PO BID

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No