Overview

This trial is active, not recruiting.

Conditions ovarian cancer, peritoneal cancer, fallopian tube cancer
Treatment tumor collection
Sponsor Beth Israel Deaconess Medical Center
Collaborator Dana-Farber Cancer Institute
Start date September 2008
End date August 2012
Trial size 100 participants
Trial identifier NCT00801320, 07-319

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Patients with either primary ovarian carcinoma or ovarian carcinoma in first relapse treated with DC/Ovarian tumor cells + GM-CSF
tumor collection
Tumor collected at the time of planned surgery
(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
tumor collection
Tumor collected at the time of planned surgery

Primary Outcomes

Measure
To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).
time frame: 2 years
To gain experience in appropriate clinical processing of tumor samples and determining cell yield.
time frame: 2 years

Secondary Outcomes

Measure
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.
time frame: 2 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 - 18 years of age or older Exclusion Criteria: - 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

Additional Information

Official title 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 (Ovarian Spore)
Principal investigator David Avigan, MD
Description - Even if tumor sample is collected, the participant is under no obligation to participate in the vaccine study. - Participants will have their regularly planned surgery as described by their surgeon. During the surgery, tumor samples will be collected. We will only collect tumor that is not needed and could otherwise be thrown away. - The tumor samples will be frozen and placed in storage for up to two years.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.