Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Tissue Adhesions

Cicatrix

Fibrosis

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Intraperitoneal administration: intraperitoneal bevacizumab plus carboplatin every 3 weeks for 4-6 cycles

Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Intraperitoneal administration: intraperitoneal carboplatin every 3 weeks

Systemic chemotherapy: paclitaxel, iv. every 3 weeks for 4-6 cycles

Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles

carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles

paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles

paclitaxel

Nan Du, PhD

Hui Zhao, Phd

Nan Du, Phd

Background: Malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. The incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. Malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. The peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. Further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis.

Objective: This study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. As explosive endpoints, we will examination the expression of VEGF-A in peritoneal cavity during the treatment.

Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion

Chinese PLA Generation Hospital

Quantitation of VEGF-A by enzyme-linked immunosorbent assay (ELISA), before and after intraperitoneal administration.

Degree of adhesion was measured according to NAIR's criteria by laparoscopy. Grade 0 corresponded to no adhesions, Grade 1 and 2 corresponded to filmy adhesions and grade 3 and 4 to dense adhesions. No adhesions is defined as CR, dense adhesions change to filmy adhesions is defined as PR. The total efficiency ORR was calculated by taking the sum of CR+PR.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

From randomization until documented progressive disease or death

The proportion of patients that have a best overall response of complete response (CR) or partial response (PR), as assessed by RECIST 1.1.

Chinese PLA General Hospital

Director of oncology

Carcinoma

Adenocarcinoma

Recurrence

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Cystadenocarcinoma, Mucinous

Fallopian Tube Neoplasms

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Endometrial Neoplasms

Uterine Neoplasms

Neoplasms, Cystic, Mucinous, and Serous

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Analgesics

Interleukin-2

Denileukin diftitox

Immunotoxins

Analgesics, Non-Narcotic

Immunoconjugates

Immunologic Factors

Patients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Given IP at 3 dose levels: 5mcg/kg of ONTAK, 15mcg/kg of ONTAK, or 25mcg/kg of ONTAK

denileukin diftitox

After completion of I.P. normal saline infusion, the I.P. catheter will be capped and patients will be turned/rotated for 1 hour to help facilitate I.P. bathing w/ONTAK; patients will be turned/rotated every 15 minutes in 4 different positions for a total of 1 hour

intraperitoneal administration

laboratory biomarker analysis

enzyme-linked immunosorbent assay

flow cytometry

Lupe Salazar

RATIONALE: Biological therapies, such as denileukin difitox, may stimulate the immune system in different ways and may prevent tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox in treating patients with advanced refractory ovarian cancer, primary peritoneal carcinoma, or epithelial fallopian tube cancer.

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose of intraperitoneal administration of ONTAK. SECONDARY OBJECTIVES: I. To evaluate the change in the number of Tregs in the peritoneum with the administration of ONTAK. II. To evaluate the change in the number of Tregs in the peripheral blood with the administration of ONTAK. III. To assess the clinical impact of ONTAK on tumor burden by serial measurements of CA-125. IV. To assess the level of circulating cytokines IL-2, IL-6, IL-10, TGF-beta2, and TNF-alpha in the peritoneum and peripheral blood before and after I.P. ONTAK. OUTLINE: This is a dose escalation study. Patients receive intraperitoneal denileukin diftitox over at least 15 minutes on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of denileukin diftitox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After the completion of study treatment, patients are followed up at 1 and 2 weeks, monthly for 3 months, and then at 6 months.

Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer

Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK® Administered to Patients With Advanced Stage Ovarian Cancer

National Cancer Institute (NCI)

University of Washington

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital
Intraperitoneal Chemotherapy Alone or in Combination With Bevacizumab for Ovarian Cancer With Peritoneal Adhesion	NCT03095001	Peritoneal Adhe...	Bevacizumab Carboplatin paclitaxel	18 Years - 70 Years	Chinese PLA General Hospital
Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer	NCT00357448	Fallopian Tube ... Ovarian Clear C... Ovarian Endomet... Ovarian Mixed E... Ovarian Mucinou... Ovarian Serous ... Ovarian Undiffe... Peritoneal Cavi... Recurrent Ovari... Stage III Ovari... Stage IV Ovaria...	denileukin dift... intraperitoneal... laboratory biom... enzyme-linked i... flow cytometry	18 Years -	University of Washington

Spots Global Cancer Trial Database for intraperitoneal administration