Clinical trial · Interventional
Mesenchymal Stem Cells (MSC) for Ovarian Cancer
Phase 1 Study to Determine the Effects of Mesenchymal Stem Cells Secreting Interferon Beta in Patients With Advanced Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSC-INFβ | Genetic | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mesenchymal Stem Cells + Interferon Beta (MSC-INFβ)
- description
- 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.
- interventionNames
- Genetic: MSC-INFβ
- Behavioral: Questionnaires
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of Mesenchymal Stem Cells-Interferon-β (MSC-IFNβ)
- timeFrame
- 5 weeks
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. Patient must have recurrent epithelial ovarian cancer and may have received unlimited prior chemotherapeutic regimens for management of recurrent cancer. 3. 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. 4. Zubrod performance status of 0-1. 5. Absolute neutrophil count (ANC) \> 1,000/mm3 and a platelet count \> and a platelet count \> 30,000/mm3. 6. Creatinine clearance \> 50 mL/min (assessed by Cockcroft Gault estimation). 7. Bilirubin \< 1.5 x upper limit of normal (unless Gilbert's syndrome), ALT or AST \< 3 x upper limit of normal. 8. No evidence of significant cardiac or pulmonary dysfunction. 9. 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. 10. Negative pregnancy test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 11. 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. 12. Patient or patient's legal representative able to provide written informed consent. Exclusion Criteria: 1. Patients receiving anti-cancer therapy within 21 days before MSC treatment. 2. Target lesion previously embolized, perfused, or irradiated without objective evidence of progression before start of therapy to be considered for response assessment. 3. Patients with uncontrolled symptomatic brain metastases. A scan to confirm absence of brain metastasis is not required. 4. 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. 5. Symptomatic effusions due to pleural, pericardial, or peritoneal metastasis of epithelial ovarian cancer. 6. 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.
References
Publications (0)
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