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Alkylating agents

Chemoimmunotherapy + Vaccines for Recurrent Ovarian Cancer

Phase 1 & 2

Recruiting

Led By Robert P Edwards, MD

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

Patients must have advanced stage (III-IV) epithelial carcinoma of ovarian, tubal, or peritoneal origin.

Patients must have GOG performance of 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a treatment plan for advanced ovarian cancer patients. They will first receive a combination of drugs directly into the abdominal cavity and through the vein. Then, they will receive another treatment containing a

Who is the study for?

This trial is for advanced stage (III-IV) ovarian, tubal, or peritoneal cancer patients who haven't had chemo before. They must be fit enough for surgery and chemotherapy without significant health issues like kidney damage or bowel obstruction. Women of childbearing age need a negative pregnancy test and must use birth control.

What is being tested?

The study tests intensive chemoimmunotherapy with intraperitoneal Cisplatin and IV Paclitaxel followed by a chemokine modulatory regimen plus autologous αDC1 vaccines in patients receiving first-line neoadjuvant therapy to see if it improves treatment response.

What are the potential side effects?

Possible side effects include those from Cisplatin such as nausea, kidney problems, hearing loss; Celecoxib may cause stomach upset or heart issues; the DC vaccine is known to be non-toxic but could potentially cause injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced ovarian, tubal, or peritoneal carcinoma.

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I can carry out all my usual activities without help.

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I am willing to undergo a procedure to collect white blood cells.

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I am currently undergoing chemotherapy before surgery.

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I am eligible for initial treatment with chemotherapy before surgery.

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I have not received chemotherapy and am getting my first treatment before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid.

Number of adverse events for the different combinations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cisplatin + Celecoxib + DC VaccineExperimental Treatment1 Intervention

Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + intranodal vaccine injections once per cycle

Group II: Cisplatin + CKM + Celecoxib + DC VaccineExperimental Treatment1 Intervention

Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + IFN by IP once per cycle + rintatolimod 200 mg by IP once per cycle + intranodal vaccine injections once per cycle

0 / 6Eligibility criteria met