Salvage Ovarian FANG™ Vaccine + Bevacizumab

Part of paid clinical trials in Dallas, Texas.

Sponsor
Gradalis, Inc.
Study ID
NCT01551745
Phase
PHASE2
Status
Completed

Conditions

  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vigil™ Vaccine — BIOLOGICAL
    Patients meeting eligibility criteria will receive Autologous Vigil™ vaccine will be supplied by Gradalis,Inc. Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).
  • Bevacizumab — DRUG
    Patients meeting eligibility criteria will receive bevacizumab 10 mg/kg intravenously every 2 weeks.

Study Details

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with bevacizumab. All patients will have had Vigil™ prepared and stored from initial primary surgical debulking. Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 4 weeks and bevacizumab 10 mg/kg intravenously every 2 weeks.

Key Dates

First listed
Mar 13, 2012
Start date
Mar 31, 2012
Status verified
Oct 2021
Primary completion
Apr 30, 2016
Completion
Apr 30, 2016

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vigil™ Vaccine
    Patients will receive 1.0 x 10e7 cells via intradermal injection one day each cycle for a maximum of 12 doses as long as sufficient material is available and subject is clinically stable. Additionally, patients will receive bevacizumab 10 mg/kg intravenously (prior to Vigil™ administration) every 2 weeks (4 weeks=1 cycle).

Primary Outcome Measure

Time to Progression [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mary Crowley Cancer Research CentersDallasTexas75230-

Find similar trials in Dallas, TX

By research site
Mary Crowley Cancer Research Centers· Dallas, TX

Related Studies