Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme

NCT00390299 | Completed Phase 1 Results

• 4 other identifiers: MC0671NCI-2009-01198P30CA015083P50CA108961
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of carcinoembryonic antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Conditions

Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Glioma; Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

• Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I) Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities

  The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include hematologic events grade 3 or higher (except grade 3 ANC lasting \< 72 hours), non-hematologic events graded 3 or higher (except grade 3 nausea, vomiting, or diarrhea were to be considered DLT only if patient was receiving the max supportive care and alopecia was not considered dose limiting), neurologic toxicity grade 2 or higher, grade 2 allergic reactions asymptomatic bronchospasm and/or urticarial, grade 3 or higher allergic reactions, viremia lasting for 6 weeks or more from last viral administration deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event are reported.

  2 weeks

• Number of Patients Experiencing Grade 3+ Adverse Events, Per NCI CTCAE Version 3.0

  The number of patients experiencing grade 3+ adverse events (overall and by arm) will be tabulated and summarized in this patient population.

  Up to 2 weeks

Secondary Outcomes (3)

• Best Response, Defined as the Best Objective Status Recorded From the Start of the Treatment Until Disease Progression/Recurrence

  Up to 2 weeks

• Progression-free Survival (PFS)

  Length of time from date of registration to a) date of progression or death due to any cause or b) last follow-up, assessed up to 6 months

• Survival

  Up to 13 years

Other Outcomes (9)

• CEA Titers

  Up to 15 years

• Change in CD4 Counts

  Baseline to day 28

• Change in CD46 Status

  Baseline to up to day 5

Study Arms (2)

Arm A (resection cavity administration)

EXPERIMENTAL

Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by MV-CEA administered into the resection cavity.

Biological: Carcinoembryonic Antigen-Expressing Measles Virus; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery

Arm B (intratumoral and resection cavity administration)

EXPERIMENTAL

Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by MV-CEA IT through the catheter over 10 minutes on day 1. Patients then undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed.

Biological: Carcinoembryonic Antigen-Expressing Measles Virus; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery

Interventions

Carcinoembryonic Antigen-Expressing Measles Virus BIOLOGICAL

Given via injection into resection cavity or around tumor bed and/or IT

Also known as: MV-CEA

Arm A (resection cavity administration); Arm B (intratumoral and resection cavity administration)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (resection cavity administration); Arm B (intratumoral and resection cavity administration)

Therapeutic Conventional Surgery PROCEDURE

Undergo en bloc resection

Arm A (resection cavity administration); Arm B (intratumoral and resection cavity administration)

Eligibility Criteria

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

You may qualify if:

• Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
• Candidate for gross total or subtotal resection
• Absolute neutrophil count (ANC) \>= 1500/uL
• Platelets (PLT) \>= 100,000/uL
• Total bilirubin =\< 1.5 x upper normal limit (ULN)
• Aspartate aminotransferase (AST) =\< 2 x ULN
• Creatinine =\< 2.0 x ULN
• Hemoglobin (Hgb) \>= 9.0 gm/dL
• Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.3 x ULN
• Ability to provide informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of \>= 1.1 EU/ml as determined by enzyme immunoassay
• Normal serum CEA levels (\< 3 ng/ml) at the time of registration
• Willing to provide biologic specimens as required by the protocol
• Negative serum pregnancy test done =\< 7 days prior to registration (for women of childbearing potential only)

You may not qualify if:

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Active infection =\< 5 days prior to registration
• History of tuberculosis or history of purified protein derivative (PPD) positivity
• Any of the following therapies:
• Chemotherapy =\< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
• Immunotherapy =\< 4 weeks prior to registration
• Biologic therapy =\< 4 weeks prior to registration
• Bevacizumab =\< 12 weeks prior to registration
• Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =\< 2 weeks prior to registration
• Radiation therapy =\< 6 weeks prior to registration
• Any viral or gene therapy prior to registration
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment

Sponsors & Collaborators

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

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Astrocytoma; Oligodendroglioma; Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

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

Galanis.Evanthia@mayo.edu

+1 (507) 266-0584

Study Officials

• Evanthia Galanis

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: October 23, 2006
• Primary Completion: November 29, 2018
• Study Completion: November 30, 2019
• Last Updated: January 2, 2020
• Results First Posted: January 2, 2020

Record last verified: 2019-01

Locations

US (1)