Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
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Purpose
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of viral therapy in treating patients with recurrent glioblastoma multiforme.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Brain Tumor Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor |
Biological: carcinoembryonic antigen-expressing measles virus Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM) |
- Toxicity profile as assessed by NCI CTC version 3.0 [ Designated as safety issue: Yes ]
- Adverse events profile [ Designated as safety issue: Yes ]
- Response profile [ Designated as safety issue: No ]
- Time until any treatment related toxicity, time until treatment related grade 3+ toxicity, and time until hematologic nadir (WBC, ANC, platelets) [ Designated as safety issue: Yes ]
- Time to progression and time time to treatment failure [ Designated as safety issue: No ]
- Laboratory correlates [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2006 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients are assigned to 1 of 2 sequential treatment groups. GROUP 1 (RESECTION CAVITY ADMINISTRATION): Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by recombinant measles virus encoding human carcinoembryonic antigen (MV-CEA) administered into the resection cavity over 10 minutes. GROUP 2 (INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION): Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by MV-CEA administration into the tumor through the catheter over 10 minutes on day 1. Patients 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
Given IV
Other Name: MV-CEA
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Correlative study
|
Detailed Description:
OBJECTIVES:
I. To assess the safety and toxicity of intratumoral and resection cavity administration of an Edmonston's strain measles virus genetically engineered to produce CEA (MV-CEA) in patients with recurrent glioblastoma multiforme.
II. To determine the maximum tolerated dose (MTD) of MV-CEA. III. To characterize viral gene expression at each dose level as manifested by CEA titers.
IV. To asses viremia, viral replication, and measles virus shedding/persistence following intratumoral administration.
V. To assess humoral and cellular immune response to the injected virus. VI. To assess in a preliminary fashion antitumor efficacy of this approach.
OUTLINE: Patients are assigned to 1 or 2 sequential treatment groups.
GROUP 1 (RESECTION CAVITY ADMINISTRATION): Patients undergo en block resection of their tumor (after confirming diagnosis) on day 1, followed by recombinant measles virus encoding human carcinoembryonic antigen (MV-CEA) administered into the resection cavity over 10 minutes.
GROUP 2 (INTRATUMORAL AND RESECTION CAVITY ADMINISTRATION): Patients undergo stereotactic biopsy (to confirm the diagnosis) and placement of a catheter within the tumor, followed by MV-CEA administration into the tumor through the catheter over 10 minutes on day 1. Patients undergo en block resection of their tumor with computer-assisted stereotactic techniques on day 5, followed by MV-CEA administered around the tumor bed.
After completion of study treatment, patients are followed periodically for up to 15 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- PLT >= 100,000/uL
- Must have central review prior to registration
- Candidate for gross total or subtotal resection
- Ability to provide informed consent
- Willing to provide biological specimens as required by the protocol
- Normal serum CEA level (< ng/ml) at the time of registration
- Recurrent grade 4 astrocytoma and grade 4 gliosarcoma with histological confirmation at primary diagnosis and/or recurrence
- Negative serum pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)
- Anti-measles virus immunity as demonstrated by IgG anti-measles antibody levels of >= 20 EU/ml as determined by Enzyme Immunoassay
- Grade 3 astrocytoma patients with clinical or imaging characteristics suggestive of progression to grade 4 are eligible, provided that the diagnosis of grade 4 astrocytoma is confirmed by biopsy (including confirmation in frozen section) prior to viral administration
- Total bilirubin =< 1.5 x upper normal limit (ULN)
- AST =< 2 x ULN
- Creatinine =< 2.0 x ULN
- Hgb >= 9.0 gm/dL
- PT and aPTT =< 1.3 x ULN
- ECOG performance status (PS) 0, 1 or 2
- ANC >= 1500/uL
Exclusion Criteria:
- Pregnant women
- Nursing women
- 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
- New York Heart Association classification IV
- Requiring blood product support
- Inadequate seizure control
- Expected communication between ventricles and resection cavity as a result of surgery
- History of organ transplant
- History of chronic hepatitis B or C
- Exposure to household contact =< 15 months old or household contact with known immunodeficiency
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination
- Chemotherapy =< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
- Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA -approved indication and in the context of research investigation)
- History of tuberculosis or history of PPD positivity
- Biologic therapy =< 4 weeks prior to registration
- Non-cytotoxic antitumor drugs (i.e., small molecular cell cycle inhibitors) =< 2 weeks prior to registration
- HIV-positive test result or history of other immunodeficiency
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Active infection =< 5 days prior to registration
- Immunotherapy =< 4 weeks prior to registration
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00390299
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Referral Office 855-776-0015 | |
| Principal Investigator: Evanthia Galanis | |
| Principal Investigator: | Evanthia Galanis | Mayo Clinic |
More Information
No publications provided
| Responsible Party: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00390299 History of Changes |
| Other Study ID Numbers: | MC0671, NCI-2009-01198, MC0671, P30CA015083 |
| Study First Received: | October 18, 2006 |
| Last Updated: | October 27, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Brain Neoplasms Glioblastoma Astrocytoma Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type |
Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors |
ClinicalTrials.gov processed this record on March 03, 2015