NCT00801320

Brief Summary

The purpose of this research study is to collect tumor samples at the time of surgery and store them for possible use as part of an experimental vaccine study for the participants cancer in the future.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable ovarian-cancer

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable ovarian-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

11.9 years

First QC Date

December 2, 2008

Last Update Submit

September 9, 2020

Conditions

Ovarian CancerPeritoneal CancerFallopian Tube Cancer

Keywords

tumor harvesttumor collectiontumor storage

Outcome Measures

Primary Outcomes (2)

  • To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).

    2 years

  • To gain experience in appropriate clinical processing of tumor samples and determining cell yield.

    2 years

Secondary Outcomes (1)

  • Based on feasibility of collection of blood samples of subjects, quantification of T cell subsets, regulatory T cells, activated memory effector cells, and DC phenotype at pre-surgery and post-surgery time points.

    2 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF

Procedure: Tumor collection

Cohort 2

EXPERIMENTAL

Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF and topical Imiquimod at site of vaccination

Procedure: Tumor collection

Interventions

Tumor collectionPROCEDURE

Tumor collected at the time of planned surgery

Cohort 1Cohort 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist
  • Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease
  • Estimated life expectancy of 6 months or greater
  • years of age or older

You may not qualify if:

  • More than one prior chemotherapy regimen
  • 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
  • Known HIV infection
  • Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin
  • Significant autoimmune disease, including psoriasis
  • History of clinically significant venous thromboembolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • David Avigan, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

US(4)