Phase 1
N=37
Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Ovarian Cancer · Primary Peritoneal Cavity Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00408590 ↗Enrolled (actual)
37
Serious AEs
13.5%
Results posted
Oct 2017
Primary outcome: Primary: Dose Limiting Toxicity — 0; 0 participants with DLTs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- carcinoembryonic antigen-expressing measles virus (Biological); oncolytic measles virus encoding thyroidal sodium iodide symporter (Biological); reverse transcriptase-polymerase chain reaction (Genetic); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity |
0; 0 | — |
| SECONDARY Number of Responses (Complete and Partial, Stable and Progressive Disease) |
0; 0; 0; 0; 14; 13 | — |
| SECONDARY Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months) |
-20.2; 97; 52; 42.5; 129; -112 | — |
| SECONDARY Time to Progression |
55; 64.5 | — |
Summary
RATIONALE: A gene-modified virus may be able to kill tumor cells without damaging normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of an attenuated oncolytic measles virus therapy and oncolytic virus therapy in treating patients with progressive, recurrent, or refractory ovarian epithelial cancer or primary peritoneal cancer (measles virus vaccine therapy study closed as of 06/02/2008).
Eligibility Criteria
Inclusion criteria
- Age ≥ 18 years.
- Must have persistent, recurrent or progressive ovarian cancer or primary peritoneal cancer after prior treatment with platinum and taxol compounds. Histologic confirmation of the original primary tumor is required. Prior bilateral oophorectomy is required.
- Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma NOS
- The following laboratory values obtained ≤7 days prior to registration:
- ANC ≥ 1500/μL
- PLT ≥ 100,000/μL
- Total bilirubin ≤ upper normal limit
- AST ≤ 2 x ULN
- Creatinine ≤ 1.5 x ULN
- Hgb ≥ 9.0 g/dL
- Ability to provide informed consent.
- Willingness to return to Mayo Clinic Rochester for follow-up.
- Life expectancy ≥ 12 weeks.
- Must have anti-measles immunity as demonstrated by serum IgG anti-measles antibody levels of ≥ 20.0 EU/ml as determined by Enzyme Immunoassay (Diamedix, FL).
- Must have normal serum CEA levels ( 6 mo from completion of primary (adjuvant) chemotherapy.
- ECOG performance status (PS) 3 or 4.
- Active infection ≤5 days prior to registration.
- History of tuberculosis or history of PPD positivity.
- History of other malignancy ≤5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix.
- Any of the following prior therapies:
- Chemotherapy ≤ 3 weeks prior to study entry
- Immunotherapy ≤ 4 weeks prior to study entry
- Biologic therapy ≤ 4 weeks prior to study entry
- Extensive abdominal surgery if it includes enterotomy(ies) 8 cm in diameter at the time of registration, intrahepatic disease, or disease beyond the abdominal cavity.
- Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids.
- Exposure to household contacts ≤15 months old or household contact with known immunodeficiency.
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
- Allergy to iodine. This does not include reactions to intravenous contrast materials.
Data sourced from ClinicalTrials.gov (NCT00408590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.