The Evaluation of minocycline effect in patients with resistant malignant ascites

Phase 2

Recruiting

• Conditions: resistant malignant ascites.; Secondary malignant neoplasm of retroperitoneum and peritoneum, Malignant ascites NOS

• Registration Number: IRCT20140113016200N2
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Have metastatic progressive cancer and resistant malignant ascites with no answer to the routine treatments.
older than 18 years.
Complete written informed consent form in accordance with Ministry of Health guidelines included in this study.
Have healthy liver and kidney function.
Have estimated lifetime of at least 12 weeks.
Should have a measurable disease according to the criteria for evaluation of response to solid tumors (RECIST).
At least 3 weeks after the past chemotherapy for improvement of reversible side effects (and at least 6 weeks for chemotherapy drugs that have toxic effects on the stem cells)
At least 2 weeks away from previous radiotherapy and in general less than 25% of the bone marrow should be exposed.
A patient with previously treated CNS metastasis is eligible only if there is no clinical or radiological evidence of CNS disease progression.
Before starting the treatment, complete medical history and physical examination, measurement of height, weight, vital signs, pain score, ECOG score (this test indicates an increase in internal ear pressure in some patients), urine test, pregnancy test, Chest X-ray, ECG, serum biochemical testing including glucose and Cholesterol, electrolytes, urea, creatinine, complete blood count, liver function tests, and measuring tumor markers and VEGF and IL-6 have been done.

Exclusion Criteria

Ascites caused by other factors (e.g., kidney or heart failure, severe liver dysfunction / or occlusion of portal vein and peritoneal inflammation).
Severe malnutrition or indigestion (with a BMI less than 19 kg / cm2 and/or hypoproteinemia with serum albumin less than 20 g/ L).
Inadequate blood function (Total neutrophil count less than 1500 / MM3 and platelet less than 100,000 / MM3).
Severe infection requiring treatment.
Coagulopathy or Encephalopathy.
Other severe complications that are diagnosed by early examination, such as pregnancy or lactation or psychiatric disorders.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The volume of ascitic fluid, CA125, VEGF, IL-6. Timepoint: Once at the beginning, then every two weeks for two months. Method of measurement: Ultrasound + ascitic fluid and blood sampling.