Mesenchymal Stem Cells (MSC) for Ovarian Cancer

Completed · Phase 1

Conditions studied: Ovarian Cancer

In brief

The goal of this clinical research study is to find the highest tolerable dose of human mesenchymal stem cells with interferon beta (MSC-INFb) that can be given to patients with ovarian cancer and to test the safety of the MSC-INFb. This is an investigational study. MSC-INFb infusions for ovarian cancer is investigational. Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.

Key facts

Study ID

NCT02530047

Run by

M.D. Anderson Cancer Center

People needed

5

Starts

2016-05-16

Expected to finish

2019-06-13

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be 18 to 90 years in age with histologically documented diagnosis of epithelial ovarian cancer including serous papillary, endometrioid, mucinous, clear cell, poorly differentiated or mixed adenocarcinomas.
• Patient must have recurrent epithelial ovarian cancer and may have received unlimited prior chemotherapeutic regimens for management of recurrent cancer.
• Patients should have measurable disease as defined by RECIST 1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) that is accessible to biopsy.
• Zubrod performance status of 0-1.
• Absolute neutrophil count (ANC) > 1,000/mm3 and a platelet count > and a platelet count > 30,000/mm3.
• Creatinine clearance > 50 mL/min (assessed by Cockcroft Gault estimation).
• Bilirubin < 1.5 x upper limit of normal (unless Gilbert's syndrome), ALT or AST < 3 x upper limit of normal.
• No evidence of significant cardiac or pulmonary dysfunction.
• Patient must have a hemoglobin >/= 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days before registration. If a patient receives packed red blood cell transfusion to achieve a hemoglobin level of >/= 9 gm/dl, the hemoglobin level needs to be stable (no drop by more than 1 gm/dl from the post-transfusion hemoglobin level) for at least 1 week.
• Negative pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
• Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months following last treatment.
• Patient or patient's legal representative able to provide written informed consent.

You may not qualify if…

• Patients receiving anti-cancer therapy within 21 days before MSC treatment.
• Target lesion previously embolized, perfused, or irradiated without objective evidence of progression before start of therapy to be considered for response assessment.
• Patients with uncontrolled symptomatic brain metastases. A scan to confirm absence of brain metastasis is not required.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic obstructive pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
• Symptomatic effusions due to pleural, pericardial, or peritoneal metastasis of epithelial ovarian cancer.
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other cancer from which the patient has been disease-free for 5 years. Patients may have dual primaries of endometrial and ovarian cancer.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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