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Cancer Vaccine
Dendritic Cells + Natural Killer Cells for Ovarian Cancer
Phase 1 & 2
Waitlist Available
Led By Kunle Odunsi
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is studying side effects and best dose of natural killer cell-like cytotoxic T-lymphocytes (CTLs) when given with a vaccine in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Eligible Conditions
- Peritoneal Cancer
- Ovarian Cancer
- Fallopian Tube Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in immune response
Dose-limiting toxicities (DLT) assessed by CTCAE version 5
Incidence of adverse events as assessed by Cancer Therapy Evaluation Program (CTEP) version 4 of the Common Terminology Criteria for Adverse Events (CTCAE)
+1 moreSecondary outcome measures
T cell populations and higher anti-tumor responses
Other outcome measures
Overall survival assessed by irRECIST
Progression-free survival assessed by immune-related response criteria (irRECIST)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nCTLs, alpha-DC1 vaccine)Experimental Treatment2 Interventions
Patients receive the alpha-type-1 polarized dendritic cell vaccine ID 2 weeks before day 0, on day 0, and on day 28. Patients also receive aDC1 IP over 3-10 seconds on day 0. In the absence of unacceptable side effects, patients may receive the alpha-type-1 polarized dendritic cell vaccine every 1-3 months at the discretion of the physician.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,153 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,858 Total Patients Enrolled
4 Trials studying Ovarian Cancer
63 Patients Enrolled for Ovarian Cancer
Kunle OdunsiPrincipal InvestigatorRoswell Park Cancer Institute
7 Previous Clinical Trials
135 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 6 more months.You are regularly taking immune-weakening medications like cyclosporin, ACTH, or long-term corticosteroids.You have a type of tumor that is not very likely to spread, except for a specific type called ovarian pseudomyxoma, or if there is no spread of the tumor in the abdomen at the beginning.You have had other types of cancer, except for nonmelanoma skin cancer, in the past three years.Your absolute neutrophil count is 1,000 or more per microliter of blood.Your platelet count is at least 75,000 per microliter.Your hemoglobin level must be 8.0 grams per deciliter or higher.Your bilirubin level in the blood is within a certain range.Your creatinine levels are no more than two times the normal limit.Your alkaline phosphatase levels are not more than 3 times the upper limit of normal.Your SGOT blood test result is less than or equal to three times the upper limit of normal.Cancer has spread to the brain or any area above the diaphragm.You have serious infections or bleeding disorders.You have an ongoing autoimmune disease that requires long-term use of steroids or other medications that lower the immune system.You are able to perform daily activities without any help or with a little help.You have a condition that weakens your immune system.You have other uncontrolled health problems aside from cancer that could affect how well the treatment works or its side effects.You currently abuse drugs or alcohol, or have a mental health condition that could affect the study.You can have a device placed in your abdomen, and you don't have a history of certain infections or bowel problems.You have a tumor that is at least 1 cm in size that was removed during surgery.You are not currently being treated for any infections, except for a simple urinary tract infection.Women with advanced ovarian, fallopian tube, or peritoneal cancer who have little or no sign of the disease after their first treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nCTLs, alpha-DC1 vaccine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled slots available for this research trial?
"This medical trial, which was initially posted on 15th December 2022 and most recently updated on 1st November 2022, is no longer looking to recruit candidates at this time. However, 622 other trials currently have openings for volunteers."
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