Study on Intensive Chemoimmunotherapy and Intranodal Vaccines for Recurrent Ovarian Cancer

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02432378

Provider View

This clinical trial is testing a new treatment approach for advanced ovarian cancer, combining intensive chemotherapy and immunotherapy with intranodal vaccines to see if it can improve patient outcomes.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of a new treatment for advanced ovarian cancer. This treatment involves a combination of intensive chemotherapy and immunotherapy, followed by vaccines injected into the lymph nodes. The goal is to see if this approach can help control the cancer more effectively. In the first phase, researchers determined the safe dose of the treatment. In the second phase, they are adding a vaccine known to be safe to see if it increases the treatment's effectiveness.

Description

In the first phase of the study, patients received up to 6 cycles of intensive chemotherapy, with additional immunotherapy from the second to the sixth cycle. In the second phase, which began on August 27, 2024, patients will receive up to 6-8 cycles of chemotherapy, along with injections of a vaccine and immunotherapy. To enhance the immune response, all patients will also take an oral medication called celecoxib.

Eligibility Criteria

Inclusion Criteria

  • Have advanced stage (III-IV) ovarian, tubal, or peritoneal cancer.
  • Have a pathology report confirming the original tumor diagnosis.
  • Provide original tumor samples for review.
  • Be receiving initial chemotherapy before surgery.
  • Be eligible for cancer treatment with initial chemotherapy.
  • Have not received prior chemotherapy and are in the first line of treatment.
  • Have a performance status score of 0 or 1, indicating good overall health.
  • Be suitable candidates for surgery and chemotherapy without significant abdominal issues.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception. Breastfeeding must be stopped before treatment.
  • Be willing to undergo a procedure to collect white blood cells.
  • Agree to regular health monitoring during the study.
  • Have adequate bone marrow, kidney, and liver function as shown by specific blood tests.
  • Sign an informed consent form and agree to share health information.
  • Have a performance status score of 0 or 1.

Exclusion Criteria

  • Have an active autoimmune disease like rheumatoid arthritis or lupus.
  • Have allergies to specific chemotherapy drugs, unless they can tolerate a test dose.
  • Are taking long-term immunosuppressive medications.
  • Have an immune deficiency disorder.
  • Have uncontrolled health conditions other than cancer.
  • Are pregnant or breastfeeding.
  • Have conditions that prevent the use of certain pain medications.
  • Have tumors with low potential for spreading, except specific types.
  • Have had another invasive cancer within the last five years, unless it's non-melanoma skin cancer.
  • Have had previous pelvic radiation therapy.

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