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Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With GM-CSF and Imiquimod


- Patients must have undergone therapeutic debulking surgery for independent clinical
indications and have tissue frozen and stored under sterile conditions as part of
protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a
Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal
Cancer)

- Participants will be assigned to one of two study groups. Both groups will undergo a
procedure known as leukapheresis by which the white blood cells are removed from the
participants blood in order to obtain the dendritic cells. Prior to this procedure
participants may receive 4 injections of GM-CSF, which helps increase the white blood
cell count.

- If enough cells are obtained during the leukapheresis, tumor cells and dendritic cells
will then be fused (mixed) together in the laboratory and divided into the appropriate
doses for administration.

- Participants assigned to Group 1 will undergo subcutaneous vaccination with the
dendritic cell tumor fusion vaccine. On the day of the vaccine and three days
afterwards, they will receive GM-CSF injections at the site of the vaccination.
Participants will receive a dose of the vaccine every 3 weeks for a total of 3
vaccinations.

- Participants assigned to Group 2 will undergo subcutaneous vaccination with the
dendritic cell tumor fusion vaccine. On the day of the vaccine and three days
afterwards, they will receive GM-CSF injection at the site of the vaccination.
Additionally, imiquimod cream will be applied to the skin at the injection sight 2
hours before the vaccine administration. Participants will continue to apply imiquimod
cream at the site of vaccination for 3 days following the injection. Participants will
receive a dose of the vaccine every 3 weeks for a total of 3 vaccinations.

Inclusion Criteria


Inclusion criteria at time of initial enrollment:

- Patients must have undergone therapeutic debulking surgery for independent clinical
indications and have tissue frozen and stored under sterile conditions as part of
protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a
Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal
Cancer)

- Patients with histologically proven stage III or IV ovarian, fallopian tube or
primary peritoneal serous carcinoma (or patients of any stage with recurrent disease)
who demonstrate lack of disease progression as determined by clinical assessment as
well as CA-125 levels and/or radiographic assessment

- Patients must have ECOG performance status of 0-2 with greater than six week life
expectancy.

- All patients must be informed of the investigational nature of this study and must
give written informed consent in accordance with institutional and federal
guidelines.

- Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL,
Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN

Eligibility criteria prior to first vaccination

At a maximum of twelve weeks after the last dose of chemotherapy, patients must fulfill
the following criteria:

- Complete clinical response after first-line chemotherapy for newly-diagnosed
patients, or after second-line chemotherapy for relapsed patients who require
secondary cytoreduction.**

- Asymptomatic, low volume disease not requiring further chemotherapy prior to
initiating vaccination

** Complete clinical response is defined as normal exam, normal CT scan, and normal
CA-125 level. Tumor tissue for relapsed patients would be obtained under informed
consent at the time of a secondary surgical debulking, which would be performed as
part of standard relapse management in appropriate patients.

- Resolution of all chemotherapy related grade III-IV toxicity

- Laboratories:WBC > 2.0 X 103/uL, Platelets > 50,000/uL, Bilirubin < 2.0 mg/dL
Creatinine <2.0 mg/dL, AST/ALT < 2.5 x ULN

Exclusion Criteria:

- Patient with progressive disease during first line chemotherapy with a
platinum/taxane combination will be excluded.

- Patients must not have clinically significant autoimmune disease that requires
treatment with immunosuppressant medications.

- Because of compromised cellular immunity and limited capacity to respond to
vaccination, patients who are HIV+ will be excluded.

- Patients must not have serious intercurrent illness such as infection requiring IV
antibiotics, or significant cardiac disease characterized by significant arrhythmia,
unstable ischemic coronary disease or congestive heart failure.

- Pregnant and/or lactating women will be excluded. Premenopausal patients will undergo
pregnancy testing when indicated. Women will practice effective birth control while
receiving protocol treatment.

- Patients with a history of clinically significant venous thromboembolism will be
excluded.

- Active second malignancy, aside from basal cell or squamous cell carcinoma of the
skin (i.e. malignancy not treated with curative intent or diagnosis within the past 2
years)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if cellular immunity is induced by serial vaccination with DC/tumor fusion cells, when given with GM-CSF alone, or the combination of GM-CSF and imiquimod in this patient population.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

07-380

NCT ID:

NCT00799110

Start Date:

August 2008

Completion Date:

June 2013

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • dendritic cells
  • fusion vaccines
  • GM-CSF
  • imiquimod
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Brigham & Women's HospitalBoston, Massachusetts  02115