Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod

NCT00799110 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 07-380
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.

Conditions

Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Keywords

dendritic cells; fusion vaccines; GM-CSF; imiquimod

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• To assess toxicity associated with vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.

  2 years

• To assess clinical response to vaccination with DC/tumor fusion when given with GM-CSF and imiquimod.

  2 years

• To correlate immunologic response following vaccination with measures of patient cellular immune function and phenotypic characteristics of the vaccine preparation.

  2 years

Study Arms (2)

Group 2

EXPERIMENTAL

Vaccine, GM-CSF and imiquimod,

Drug: GM-CSF; Biological: Dendritic Cell/Tumor Fusion Vaccine; Drug: imiquimod

Group 1

EXPERIMENTAL

Vaccination plus GM-CSF

Drug: GM-CSF; Biological: Dendritic Cell/Tumor Fusion Vaccine

Interventions

GM-CSF DRUG

Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards

Group 1; Group 2

Dendritic Cell/Tumor Fusion Vaccine BIOLOGICAL

Given subcutaneously once every three weeks for a total of three vaccines

Also known as: DC/tumor fusion vaccine

Group 1; Group 2

imiquimod DRUG

Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Imiquimod

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: November 27, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

US (4)