News

Article on the USMCI Military Oncology IRB appears in May 2011 issue of US Medicine and in July 2011 issue of the Stripe

Read more:original US Medicine article 

Read more:original Stripe article

USMCI IRB Holds Inaugural Meeting

The United States Military Cancer Institute (USMCI) held its inaugural meeting at the National Naval Medical Center (NNMC) for its new review board to examine and approve oncology research protocols for medical treatment facilities in the National Capital Area, Feb. 24.

Read more: original article

USMCI Institutional Review Board (IRB)

1.    The USMCI IRB reviewed its first protocol on Feb 24, 2011.  The IRB initially served as an Oncology central IRB for Walter Reed Army Medical Center, the National Naval Medical Center (NNMC) - Bethesda, Malcolm Grow Medical Center, and the Uniformed Services University. However, it now also offers protocol reviews for all Army, Navy, and Air Force Medical Treatment Facilities in the United States. As such, this allows for a single IRB review for multi-site protocols involving participating institutions.

2.    New proposals for the USMCI IRB to consider must be submitted through the researcher’s local institution to the USMCI.  

3.    In general, all meetings will begin at 1300 HRS in Bldg 1 of the NNMC, in room 4397.

4.    If you have any questions, or would like a copy of the IRB meeting schedule, you may contact the Associate Director for Administration, William P. Mahr (LTC, USA, Ret) at USMCI, 202-782-0552 or Ms. Sheila Gaines, Assistant Department Head, Responsible Conduct of Research Service at NNMC, 301-295-6512.

Information Systems

Raul Parra, the USMCI Information Systems Manager, recently was awarded Project Management Professional (PMP) certification by the Project Management Institute.

The Project Management Institute is a non-profit organization that develops and publishes standards related to Program, Project and Portfolio management areas. These standards have been recognized in Academic Institutions as well as in Industry and Governments around the globe. They also ensure a minimum level of competency in these disciplines by developing and administering the certification material and requirements.

The PMP credential demonstrates the project management knowledge, experience and skills to bring projects to successful completion. Additionally, this credential recognizes the competence of an individual to perform in the role of a project manager, specifically experience in leading and directing projects.

This credentialing will contribute to USMCI’s growing reliance on information technology to conduct research.

USMCI Seminar -- Id Genes and Transcription Factor Networks in Hematopoietic Development

Seminar: Id Genes and Transcription Factor Networks in Hematopoietic Development

Date/Time: September 24, 2009 -- 3:30 PM

Speaker:         

Jonathan R. Keller, Ph.D

Laboratory of Cancer Prevention

Head, Hematopoiesis and Stem Cell Biology Section

National Cancer Institute at Frederick

Location:        

Uniformed Services University of the Health Sciences (USU)

Lecture Room B, Building A

4301 Jones Bridge Road, Bethesda, Maryland 20814

USMCI and USUHS Molecular & Cell Biology Seminar  “Intrinsic Therapeutic Resistance of Breast Cancer Stem Cells”

When: Wednesday, March 18, 2009 - 3:30pm

Where: Lecture Room A - USUHS

Presented by:

Jeffrey Rosen, PhD

C.C. Bell Professor of Molecular and Cellular Biology and Medicine

Distinguished Service Professor

Baylor College of Medicine

Houston, TX

The Seminar is presented by the USUHS MCB Graduate Program & co-sponsored by the US Military Cancer Institute.

USUHS: 4301 Jones Bridge Road, Bethesda, Maryland 20814

USMCI and USUHS Molecular & Cell Biology Seminar

“Novel Signaling in Cancer Cells and Development of Targeted Therapy”

When: Wednesday, February 18, 2009 - 3:30pm

Where: Lecture Room A - USUHS

Presented by:

Mien-Chie Hung, PhD

Professor & Chair, Molecular & Cellular Oncology

Professor, Surgical Oncology

Director, Breast Cancer Basic Research Program

University of Texas M.D. Anderson Cancer Center

Houston, TX

USMCI congratulates USMCI Member CPT Brian P. Monahan appointed Attending Physician to Congress

Secretary of Defense Robert M. Gates announced today that the President has nominated Navy Capt Brian P. Monahan, a former Associate Director of the USMCI, for appointment to the grade of rear admiral and assignment as attending physician to Congress. Monahan is currently serving as deputy attending physician to Congress.

USMCI Clinical Trials Program publication makes cover of the journal Cancer

Optimal dose and schedule of an HER-2/neu (E75) peptide vaccine to prevent breast cancer recurrence

BACKGROUND. E75, a HER-2/neu-derived peptide, was administered as a preventive vaccine with granulocyte-macrophage-colony-stimulating factor (GM-CSF) in disease-free lymph node-positive (NP) and lymph node-negative (NN) breast cancer (BCa) patients. The optimal biologic dose (OBD) was determined based on toxicity and immunologic response.

METHODS. Patients were vaccinated over 6 months (3, 4, or 6 times) with different doses of E75 plus GM-CSF. Toxicities were graded per National Cancer Institute Common Terminology Criteria. GM-CSF was reduced for significant toxicity. Immunologic response was measured by delayed type hypersensitivity test (DTH), and E75-specific CD8+ T-cells were quantified with human leukocyte antigen-A2:immunoglobulin G dimer and flow cytometry.

RESULTS. Ninety-nine patients (48 NP and 51 NN) were vaccinated in 7 dose groups. The OBD was 1000 g E75 plus 250 g GM-CSF monthly × 6. The optimal dose group (ODG, n = 29) experienced similar toxicities to the suboptimal dose group (SDG, n = 70), which was comprised of the remaining 6 groups. The ODG demonstrated a trend toward an increase in the average postvaccine dimer (0.87 ± 0.10% vs 0.67 ± 0.05%; P = .07), a significantly larger DTH response (21.5 ± 2.5 mm vs 11.3 ± 1.3 mm; P = .0002), and a trend toward decreased recurrences (3.4% vs 12.9%; P = .27). Compared with the SDG, the ODG had larger tumors (percentage T2: 55% vs 23%; P = .004), more positive lymph nodes (percentage NP: 76% vs 37%; P = .001), and higher grade tumors (percentage grade 3: 52% vs 30%; P = .07), but a shorter median follow-up time (20 months vs 32 months; P < .001).

CONCLUSIONS. Compared with suboptimally dosed patients, the optimally dosed E75 vaccine in disease-free BCa patients had similar toxicity but enhanced HER-2/neu-specific immunity that may lead to decreased recurrences with additional follow-up. Cancer 2008;113:1666-75.
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USMCI Clinial Trials Program paper is published in the journal of Clinical Cancer Research

Purpose: E75 is an immunogenic peptide fromthe HER2/neu protein, which is overexpressed in many breast cancer patients.We have conducted two overlapping E75 vaccine trials to prevent recurrence in node-positive (NP) and node-negative (NN) breast cancer patients.

Experimental Design: E75 (HER2/neu 369-377) + granulocytemacrophage colony-stimulating factor was given intradermally to previously treated, disease-free NP breast cancer patients in a dose escalation safety trial and to NN breast cancer patients in a dose optimization study. Local and systemic toxicity was monitored. Immunologic responses were assessed using in vitro assays and in vivo delayed-type hypersensitivity responses. Clinical recurrences were documented.

Results: One hundred and eighty-six patients were enrolled in the two studies (NP, 95; NN, 91). Humanleucocyte antigen A 2 (HLA-A 2) and HLA-A 3 patients were vaccinated (n =101),whereas all others (n = 85) were followed prospectively as controls. Toxicities were minimal, and a dose-dependent immunologic response to the vaccine was shown. Planned primary analysis revealed a recurrence rate of 5.6% in vaccinated patients compared with 14.2% in the controls (P = 0.04) at a median of 20 months follow-up. As vaccine-specific immunity waned over time, the difference in recurrence lost significance at 26 months median follow-up (8.3% versus 14.8%); however, a significant difference in the pattern of recurrence persisted.

Conclusions: E75 is safe and effective in raising a dose-dependent HER2/neu immunity in HLA-A2 and HLA-A3 NP and NN breast cancer patients. More importantly, E75 may reduce recurrences in disease-free, conventionally treated, high-risk breast cancer patients. These findingswarrant a prospective, randomized phase III trial of the E75 vaccine with periodic booster to prevent breast cancer recurrences.
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USMCI Conducting Phase II Clinical Trial for Breast Cancer Vaccine

The United States Military Cancer Institute's (USMCI) Clinical Trials Group is engaged in ground-breaking research working towards cancer solutions in both military and civilian populations. One exciting study in which USMCI is currently involved is a prospective, randomized, multi-center Phase, II clinical trial investigating whether a new vaccine can prevent recurrence in disease-free, conventionally treated, node-positive and high-risk node-negative breast cancer patients who are at significant risk for recurrence.  > More