Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT00408590 | Completed Phase 1 Results DMC

• 6 other identifiers: CDR0000515008P30CA015083MC01171260-03NCI-2009-01199P50CA136393
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

ovarian clear cell cystadenocarcinoma; ovarian endometrioid adenocarcinoma; primary peritoneal cavity cancer; ovarian mixed epithelial carcinoma; ovarian mucinous cystadenocarcinoma; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma; recurrent ovarian epithelial cancer; Brenner tumor

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose

  up to 12 months after last treatment

Secondary Outcomes (3)

• Number of Responses (Complete and Partial, Stable and Progressive Disease)

  up to 12 months after last treatment

• Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)

  baseline and up to 18 months

• Time to Progression

  up to 12 months after last treatment

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Biological: carcinoembryonic antigen-expressing measles virus; Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis

Interventions

carcinoembryonic antigen-expressing measles virus BIOLOGICAL

Experimental Arm

oncolytic measles virus encoding thyroidal sodium iodide symporter BIOLOGICAL

Experimental Arm

reverse transcriptase-polymerase chain reaction GENETIC

Experimental Arm

laboratory biomarker analysis OTHER

Experimental Arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<5 mg/ml) both at the time of study entry and in any prior testing. (NOTE: Not applicable for the MV-NIS cohort.)

You may not qualify if:

• Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary.
• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy. Subjects will be excluded if this is their first relapse and they have recurred \>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) \<3 weeks prior to study entry. This criterion does not apply to placement of the peritoneal port-a-cath or lysis of adhesions at the time of study entry.
• Any viral or gene therapy prior to study entry
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment.
• New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
• Requiring blood product support.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Brenner Tumor

Interventions

Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Results Point of Contact

• Title: Evanthia Galanis, M.D.
• Organization: Mayo Clinic

galanis.evanthia@mayo.edu

(507) 284-2511

Study Officials

• Evanthia Galanis, MD

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 6, 2006
• First Posted: December 7, 2006
• Study Start: April 19, 2004
• Primary Completion: August 1, 2012
• Study Completion: November 7, 2017
• Last Updated: January 16, 2024
• Results First Posted: October 2, 2017

Record last verified: 2024-01

Locations

US (1)