Clinical trial NCT01000259: Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Official title: Validation of Tumor-Infiltrating T-Cells as a Biomarker for Advanced Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-23
Enrollment: 174
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer.

II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.

SECONDARY OBJECTIVES:

I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.

II. To validate the ability of intratumoral TILs to predict overall survival of patients with optimally debulked disease.

OUTLINE:

Patients are stratified according to status of debulked disease (suboptimal vs optimal).

Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)
* Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:

  * Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
  * Patients who have had either optimal or suboptimal cytoreductive surgery
  * Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected
* Evaluable patients must have had measurable or nonmeasurable disease
* Demographic and follow-up data available

Primary outcomes:
measure: Overall survival curves
timeFrame: Baseline
measure: Progression-free survival curves
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: George Coukos
role: PRINCIPAL_INVESTIGATOR
References: