Neoplasms

All Conditions

Rare Diseases

Liposarcoma

Retroperitoneal Neoplasms

Abdominal Neoplasms

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Retroperitoneal Liposarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Halichondrin B

Tubulin Modulators

Antimitotic Agents

Patients receive eribulin mesylate IV over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy QD 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.

Eribulin Mesylate

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Therapeutic Conventional Surgery

Lara E Davis

This phase Ib trials studies the side effects and best dose of eribulin mesylate when given together with radiation therapy in treating patients with retroperitoneal liposarcoma that can be removed by surgery. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVE:

I. To determine the recommended phase 2 dose (RP2D) of radiation and eribulin mesylate (eribulin) when used in combination for the preoperative treatment of retroperitoneal liposarcoma.

SECONDARY OBJECTIVES:

I. To assess the feasibility of a preoperative chemoradiation protocol for retroperitoneal liposarcoma.

II. To assess the surgical outcomes of retroperitoneal liposarcoma resections after preoperative chemoradiation.

III. To assess preliminary anti-tumor activity of eribulin in combination with radiation in subjects with retroperitoneal liposarcoma.

OUTLINE: This is a dose-escalation study of eribulin mesylate.

Patients receive eribulin mesylate intravenously (IV) over 2-5 minutes on days 1 and 8 and undergo intensity-modulated radiation therapy once daily (QD) 5 days a week beginning on day 8 of cycle 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery within 3-10 weeks after radiation therapy.

After completion of study treatment, patients will be followed up at 2 weeks, 9 weeks, and then every 6 months for 10 years.

Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery

A Phase 1B Trial of Preoperative Eribulin and Radiation for Retroperitoneal Liposarcoma

All adverse events will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.

The proportion of subjects, along with exact two-sided 95% confidence intervals, undergoing surgical resection before the completion of all planned chemotherapy and radiation will be reported for the study.

The proportion of subjects, along with exact two-sided 95% confidence intervals, undergoing surgical resection later than planned for any reason will be reported for the study.

Will apply a mixed effects model to analyze changes in PROMIS symptom measurements at four time points: baseline, C2D8, prior to surgery and 9 weeks postoperative (post-op).

The rate of R0 resection, along with exact two-sided 95% confidence intervals, will be reported for the study.

This rate, along with exact two-sided 95% confidence intervals, will be reported for the study.

Descriptive statistics including mean, median, standard deviation, and 95% confidence interval of pathologic response will be reported for the study.

Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The ORR, along with exact two-sided 95% confidence intervals, will be reported for the study.

Median recurrence-free survival with 95% confidence interval (CI) and survival rates at 2, 5 and 10 years will be estimated using the Kaplan-Meier method for both local and distant recurrence.

Median overall survival with 95% CI and survival rates at 2, 5 and 10 years will be estimated using Kaplan-Meier method.

Eisai Inc.

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Digestive System Diseases

Uterine Cervical Neoplasms

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genital Neoplasms, Female

Peritoneal Neoplasms

Fallopian Tube Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Disease Attributes

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

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Neoplasms

Uterine Diseases

Fallopian Tube Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Nivolumab

Antibodies

Antibodies, Monoclonal

Ipilimumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients receive nivolumab i.p. over 90 minutes on days 1, 15, and 29. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive nivolumab as in group I and ipilimumab i.p. on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic Study

Amir A Jazaeri

This phase Ib trial studies the side effects and best dose of nivolumab with or without ipilimumab in treating patients with female reproductive cancer that has come back (recurrent) or is high grade and has spread extensively throughout the peritoneal cavity (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To determine the recommended phase II dose (RP2D) of intraperitoneal (i.p.) nivolumab in combination with ipilimumab.

SECONDARY OBJECTIVES:

I. To describe the pharmacokinetics (PK), toxicities, and immune-related adverse events associated with i.p. checkpoint inhibitor therapy.

II. To estimate the clinical benefit rate (rate of partial response \[PR\], complete response \[CR\], and stable disease \[SD\] using Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 modified to include immune-related response criteria) for the expansion cohort.

EXPLORATORY OBJECTIVES:

I. To determine blood based transcriptional changes associated with pharmacokinetics (PK) time points and determine their correlation with serum drug concentrations, clinical response, and immune related adverse events.

II. To determine baseline and on-treatment molecular alteration (ribonucleic acid \[RNA\] and protein) associated with i.p. and nivolumab (Nivo) (for the expansion cohort).

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups.

GROUP I: Patients receive nivolumab i.p. over 90 minutes on days 1, 15, and 29. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive nivolumab as in group I and ipilimumab i.p. on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of the study treatment, patients are followed up every 6 weeks for at least 100 days.

Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis

Phase Ib Clinical Investigation of Intraperitoneal Ipilimumab and Nivolumab in Patients With Peritoneal Carcinomatosis Due to Gynecologic Cancers

The RP2D or the MTD is defined as the combination of ipilimumab + nivolumab with the dose limiting toxicity (DLT) rate =\< 30%. Dose-finding for the combination of ipilimumab plus nivolumab will be done using the data-augmentation continuous reassessment method (DA-CRM).

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery	NCT03361436	Liposarcoma Malignant Abdom... Malignant Retro... Malignant Scrot... Malignant Solid... Malignant Sperm...	Eribulin Mesyla... Intensity-Modul... Laboratory Biom... Quality-of-Life... Questionnaire A... Therapeutic Con...	12 Years -	OHSU Knight Cancer Institute
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis	NCT03508570	Malignant Perit... Malignant Retro... Metastatic Cerv... Metastatic Endo... Metastatic Fall... Metastatic Mali... Metastatic Ovar... Metastatic Prim... Peritoneal Carc... Platinum-Refrac... Platinum-Refrac... Platinum-Refrac... Platinum-Refrac... Platinum-Resist... Platinum-Resist... Platinum-Resist... Platinum-Resist... Recurrent Cervi... Recurrent Endom... Recurrent Fallo... Recurrent Malig... Recurrent Ovari... Recurrent Prima... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar... Stage IVA Fallo... Stage IVA Ovari... Stage IVA Prima... Stage IVB Cervi... Stage IVB Fallo... Stage IVB Ovari... Stage IVB Prima... Stage IVB Uteri...	Ipilimumab Laboratory Biom... Nivolumab Pharmacokinetic...	18 Years -	M.D. Anderson Cancer Center
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis	NCT03508570	Malignant Perit... Malignant Retro... Metastatic Cerv... Metastatic Endo... Metastatic Fall... Metastatic Mali... Metastatic Ovar... Metastatic Prim... Peritoneal Carc... Platinum-Refrac... Platinum-Refrac... Platinum-Refrac... Platinum-Refrac... Platinum-Resist... Platinum-Resist... Platinum-Resist... Platinum-Resist... Recurrent Cervi... Recurrent Endom... Recurrent Fallo... Recurrent Malig... Recurrent Ovari... Recurrent Prima... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar... Stage IVA Fallo... Stage IVA Ovari... Stage IVA Prima... Stage IVB Cervi... Stage IVB Fallo... Stage IVB Ovari... Stage IVB Prima... Stage IVB Uteri...	Ipilimumab Laboratory Biom... Nivolumab Pharmacokinetic...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for malignant retroperitoneal neoplasm