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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450814 |
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy together with cyclophosphamide may be an effective treatment for multiple myeloma.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given with or without cyclophosphamide in treating patients with recurrent or refractory multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma and Plasma Cell Neoplasm |
Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter Drug: cyclophosphamide Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry Other: immunologic technique Other: laboratory biomarker analysis Procedure: biopsy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, With or Without Cyclophosphamide, in Patients With Recurrent or Refractory Multiple Myeloma |
Estimated Enrollment: | 54 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS). Patients are stratified according to receipt of cyclophosphamide during study treatment (yes vs no). Patients are initially accrued to part 1. Once the maximum tolerated dose (MTD) of MV-NIS alone is determined, subsequent patients are accrued to part 2.
Cohorts of 3-6 patients receive escalating doses of MV-NIS* in combination with cyclophosphamide until the MTD is determined. The MTD of MV-NIS is defined as in part 1.
NOTE: *Starting dose of MV-NIS is the MTD determined in part 1.
Blood and bone marrow samples are obtained for research studies, including flow cytometry, at baseline and at week 6. Serial measurements of viral RNA in mononuclear cells are conducted in samples of blood, saliva, and urine on days 3, 8, and 15 and are tested for viral replication by quantitative reverse transcriptase-polymerase chain reaction. Measles virus-specific immunity is evaluated at baseline and on day 42.
After the completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent or refractory multiple myeloma
Previously treated with ≥ 2 nonoverlapping chemotherapeutic combinations
PATIENT CHARACTERISTICS:
No clinically significant cardiac condition or illness, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 |
Study Chair: | Angela Dispenzieri, MD | Mayo Clinic |
Investigator: | Morie A. Gertz, MD | Mayo Clinic |
Investigator: | Philip R. Greipp, MD | Mayo Clinic |
Investigator: | Robert A. Kyle, MD | Mayo Clinic |
Investigator: | Martha Q. Lacy, MD | Mayo Clinic |
Investigator: | John A. Lust, MD, PhD | Mayo Clinic |
Investigator: | S. V. Rajkumar, MD | Mayo Clinic |
Investigator: | Thomas E. Witzig, MD | Mayo Clinic |
Investigator: | Steve Zeldenrust, MD | Mayo Clinic |
Investigator: | Shaji K. Kumar, MD | Mayo Clinic |
Investigator: | Gregory Wiseman, MD | Mayo Clinic |
Investigator: | Suzanne Hayman, MD | Mayo Clinic |
Investigator: | Stephen J. Russell, MD, PhD | Mayo Clinic |
Investigator: | Raymund Razonable, MD | Mayo Clinic |
Study ID Numbers: | CDR0000530389, MAYO-MC038C, MAYO-06-005263 |
Study First Received: | March 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00450814 History of Changes |
Health Authority: | Unspecified |
refractory multiple myeloma stage III multiple myeloma |
Immunoproliferative Disorders Immunologic Factors Measles Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Paraproteinemias Cyclophosphamide Hemostatic Disorders Immunosuppressive Agents |
Recurrence Multiple Myeloma Virus Diseases Hemorrhagic Disorders Iodine Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Alkylating Agents Neoplasms, Plasma Cell |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Antineoplastic Agents Physiological Effects of Drugs Paraproteinemias Cyclophosphamide Hemostatic Disorders Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Hematologic Diseases Vascular Diseases Immunosuppressive Agents Pharmacologic Actions Multiple Myeloma Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |