NCT02530047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

May 16, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

August 19, 2015

Last Update Submit

July 16, 2019

Conditions

Ovarian Cancer

Keywords

Ovarian cancerEpithelial ovarian cancerMesenchymal Stem Cells Secreting Interferon BetaMSC-INFbQuestionnairesSurveys

Outcome Measures

Primary Outcomes (2)

  • Maximum Tolerated Dose (MTD) of Mesenchymal Stem Cells-Interferon-β (MSC-IFNβ)

    Maximum Tolerated Dose (MTD) is dose with posterior probability of dose limiting toxicities (DLTs) nearest to 30%, provided the lower bound of the 90% credible interval for the posterior probability of DLT does not exceed 30%. Dose limiting toxicities (DLTs) are those adverse events of grade 3 or 4 that occur up to 1 week after the last dose.

    5 weeks

  • Correlation Between the Number of MSC-IFNβ Infused and the Production of Interferon-β and the Number of MSC-IFNβ Detected at the Tumor Sites Via Tumor Biopsy Pre- and Post-Treatment

    5 weeks

Study Arms (1)

Mesenchymal Stem Cells + Interferon Beta (MSC-INFβ)

EXPERIMENTAL

MSC-INFβ administered on an outpatient basis via intraperitoneal (IP) infusion. Starting dose: 10\^5 MSC/kg once a week for 4 treatments. Up to 4 dose levels of MSC-INFβ tested. Symptom questionnaire completed once a week for 4 weeks.

Genetic: MSC-INFβBehavioral: Questionnaires

Interventions

MSC-INFβGENETIC

MSC-INFβ administered on an outpatient basis via intraperitoneal (IP) infusion. Starting dose: 10\^5 MSC/kg once a week for 4 treatments.

Also known as: Mesenchymal stem cells with interferon beta
Mesenchymal Stem Cells + Interferon Beta (MSC-INFβ)
QuestionnairesBEHAVIORAL

Symptom questionnaire completed once a week for 4 weeks.

Also known as: Surveys
Mesenchymal Stem Cells + Interferon Beta (MSC-INFβ)

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Interferon-betaSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Amanda L. Olson, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 20, 2015

Study Start

May 16, 2016

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

US(1)