Inside the Tulane Cancer Center

Winter 1998/1999
Headlines in this Issue:
A Message from the Director
Research: Making a Difference ACCTION Grant Awarded to Tulane
The Breast Cancer Fund Fashion Show & Luncheon
Sports for Life: Teaming Up Against Prostate Cancer
Derrick Beech, M.D., Selected Principal Investigator of P-2 Grant
A Salute to TCC Members and Friends
Index to all archived issues
Index to archived articles by topic
Editorial Staff & Contacts


A Message from the Director
Roy S. Weiner, M.D.
Director, Tulane Cancer Center

This issue highlights clinical research. We recognize that basic research on the molecular biology of cancer presents challenges that must be met, secrets that must be revealed, and opportunities that must be exploited. We recognize as well that clinical research will define the path to the prevention of cancer and to its cure. Basic research and clinical research can be likened to the quarterback and an elegible receiver on a winning football team. Each contributes talent, skill, and hard work; both are most effective as members of a well-coordinated team. Clinical research translates basic research discoveries to effective human therapies. Cancer is not unique in this regard.
Building on basic research discoveries, clinical research has defined the path to curing infectious diseases with effective antibiotics and preventing them with effective vaccines.

Building on basic research discoveries, clinical research has defined the path to controlling diabetes and will define the path to preventing the scourges of diabetes by cellular and genetic treatment.

Building on basic research discoveries, clinical research has defined the path to effective treatment of cardiovascular disease and will define the path to preventing vascular occlusive disease by genetic treatment.

In cancer, clinical research has, by exploiting the basic biological differences between cancer cells and normal cells, defined the path to curative therapy for testicular cancer, Hodgkin's disease, and some leukemias and lymphomas, and may render some breast cancers preventable.

Clinical research has a well-deserved, prominent place in the Tulane Cancer Center. We are active participants in large clinical trials whose purpose is to define treatment standards for common cancers. These trials require as many as 3,000 to 5,000 patients so that one therapeutic option may be compared reliably with another. These trials have produced advances in treating many cancers. In the aggregate, tens of thousands of lives have been saved by implementing the knowledge gained from these large clinical trials. Quality of life has been an important focus as well. A dramatic example is the trial demonstrating that "lumpectomy" is as effective as total breast amputation in curing women with breast cancer. Today women have the choice of retaining their breast intact, and more and more women who are given that choice opt to do so.

But clinical research extends far beyond the large clinical trial. Some of our clinical research uses human tumor specimens to identify unique biological properties of tumors. Biological properties may influence the aggressiveness of a tumor and the effectiveness of treatment. For example, some breast cancers that over-express a gene called Her-2-neu grow faster and resist treatment. Clinical research has demonstrated that an antibody to the gene product of Her-2-neu enhances the treatability of these tumors.

Tulane's own Dr. Andrew Schally, a Nobel laureate, demonstrated that tumors influenced by hormones can be treated by modulating the levels of those hormones. He has developed potent drugs capable of blocking the production of detrimental hormones and amplifying the effect of hormones that drecrease the rate of tumor growth. Clinical research has now demonstrated the effectiveness of these drugs in treating patients with several tumors.

As you read about the clinical research initiatives of our Tulane Cancer Center members and the office that coordinates clinical research at the TCC, remember how vital clinical research is to translating basic science discovery to improving the health and welfare of ourselves, our family, our friends, our neighbors, and the society in which we live. The Tulane Cancer Center is committed to a vigorous clinical research program and, in the year to come, the TCC will facilitate access to clinical research for patients in the Gulf South communities that are part of our expanding clinical research network.

Research: Making a Difference
Five-Year Results of a Prospective Phase II Trail of Wide-Volume Brachytherapy as the Sole Method of Breast Irradiation in Tis, T1, T2, N0-1 Breast Cancer
Robert Kuske, M.D., John Bolton, M.D., William McKinnon, M.D., Ellen Zakris, M.D., Raymond Wilenzick, Ph.D.

Many women who are candidates for breast conservation therapy (BCT) are treated by mastectomy or local excision alone. While the reasons for choosing to avoid breast irradiation are varied, the protracted 6-week course of external beam radiation therapy (EBRT) and 30 trips to a radiation facility are cited by many patients, particularly those living more than 50 miles away, the elderly, and working women. This prospective trial was designed to investigate the feasibility, toxicity, cosmesis, and local tumor control outcomes for select breast cancers treated with a 4-day course of low or high dose-rate brachytherapy.

From 1992 to 1993, 50 women with 51 breast cancers had a wide local excision, axillary dissection for invasive cancers, and either low-dose rate (LDR) or high-dose rate (HDR) brachytherapy in alternating blocks of 10 patients. Median age was 67 (range 31-84). 63% lived more than 30 minutes from the facility and 50% depended upon a friend or family member for transportation. Two patients had no transportation. Eligibility criteria were Tis, T1, T2 tumors less than 4cm in greatest dimension with negative inked microscopic surgical margins, and 0 to 3 metastatic axillary lymph nodes. The brachytherapy target volume includes 2cm of breast tissue surrounding the excision cavity, and the prescription point was the isodose curve completely encompassing that volume. LDR patients received 45 Gy in approximately 4 inpatient days and HDR patients had 32 Gy in 8 fractions separated by at least 6 hours over 4 outpatient days. 23 implants were placed with the cavity open at the time of initial excision (n=5) or at reexcision (n=18) and 28 with the wound closed, 23 at axillary dissection and 5 as a separate procedure with local anesthesia and ultrasound guidance. The median number of catheters used was 15 (range (10-19). 49 were 2-plane and 2 were triple-plane implants. Tamoxifen and/or chemotherapy began 2-6 weeks after catheter removal, as indicated. 11 patients had systemic chemotherapy at a median of 3 weeks after catheter removal, 7 with a 4-cycle doxorubicin-cyclophosphamide regimen, and 4 with 6 cycles of cyclophosphamide-methotrexate-fluorouracil; 22 patients had tamoxifen. Cosmesis was judged by strict criteria during a photographic review session by a patient, radiation oncologist, and surgeon. Median follow-up is 62 months. All patients completed threapy as planned. There have been no local breast recurrences and 3 regional lymphatic recurrences, one infraclavicular, one Rotter's, and one internal mammary. 4 patients developed distant metastases. 5 patients had marked skin erythema over the target volume and 20 had moderate-marked transient erythema at the skin entry/exit sites. 2 had localized areas of moist desquamation. 24 patients had one or more Grade 2/3 late toxicities: fat necrosis (12), telangiectasia (6), breast shrinkage (4), infection (3), pain (2), or fibrosis (1). 2 patients with symptomatic fat necrosis required surgery. Cosmesis was judged to be 70% good or excellent and 30% fair or poor.

The 5-year results of this single institution pilot trial demonstrate tumor control within the vicinity of the tumor excision site, the most common site of local failure after BCT, that compares favorably to published results with EBRT. Remote relapses typically occur after 5 years, so further follow-up will be necessary in order to demonstrate that there is not an excessive rate of recurrence in different quadrants. The acute and late toxicity of this treatment should be compared to EBRT in a future trial. RTOG 95-17 opened in 1997 and addresses the reproducibility, quality control, toxicity, cosmesis, and tumor control in a Phase II cooperative group clinical trial.

American Society for Therapeutic Radiology and Oncology, abstract presented: 28 October 1998.

Research: Making a Difference
Durable Remission of Locally Advanced Breast Cancer with Multimodality Management
Alan Miller, Ph.D., M.D.; Pam Khosla, M.D.; James Lynch, M.D.; Jan Moreb, M.D.; Suzette Cullins, M.D.; Hana Safah, M.D.; Charles Hutchison; Vincent LaRussa, Ph.D.; Kate Vellis, P.A.C.; Janet Rice, Ph.D.; Nancy Mendenhall, M.D.; Roy Weiner, M.D.

Twenty women with locally advanced breast cancer were treated between January 1991 and September 1996. The treatment regimen included 4 cycles of intensive doxorubicin (30 mg/m2/d on 3 consecutive days every 2 weeks with G-CSF support), followed by appropriate surgery, followed by high dose therapy with cyclophosphamide, carboplatin and thiotepa (STAMP V, CTCb). Of the 20 patients, 7 presented with inflammatory breast cancer, 3 with Stage IIIB, 7 with Stage IIIA, 1 with multifocal Stage IIB, and 2 with Stage UV M1 (ipsilateral supraclavicular lymph node involvement) (including one who had an inflammatory primary) disease. Six patients had not undergone mastectomy at the time of entering the protocol. These 6 received the doxorubicin in a neoadjuvant fashion and were thus evaluable for tumor response. The remaining 14 received doxorubicin as adjuvant therapy prior to intensification and transplantation. All patients underwent local-regional radiation therapy and were placed on oral tamoxifen. Doxorubicin was well tolerated in this schedule with all but 3 patients receiving all their cycles on schedule. Both BM and PBPC were easily collected after this regimen and, when reinfused, resulted in the prompt recovery of granulocytes (median 11 days to 500 absolute granulocyte count) and platelets (median 13 days to 20,000 platelets). The 6 patients who received doxorubicin prior to mastectomy all had major clinical responses, but were found to have microscopic focii of breast cancer in the mastectomy specimens. The overall treatment was well tolerated with the exception of one treatment-related death (5%). The overall and relapse free survival are 70% and 58% respectively with a median follow-up of 40 months (range 12-74 months). When the Stage IV patients are censored, the relapse-free survival rate is 69%. In the bone marrow transplant phase of treatment, the major non-hematologic toxicities were stomatitis (70%) and anorexia requiring parental nutrition (75%).

Medical Oncology (1998) 15, 89-95

ACCTION Grant
Awarded to the Tulane Cancer Center's Office of Clinical Research

The Tulane Cancer Center recently received an ACCTION (Affiliated Community Clinical Trials Integrated Oncology Network) grant in support of the TCC Office of Clinical Research from the Tulane University Hospital and Clinic in the amount of $90,000. This grant will permit us to initiate our community network development and begin providing cancer prevention and treatment services to a broad spectrum of the population in Louisiana and the Gulf Coast.

Through this grant the Tulane Cancer Center has created an opportunity to establish a network of community oncologists to participate in its clinical research agenda. The objectives of the ACCTION include the following: There are several advantages to the ACCTION for the affiliated community oncologist and, especially, for the patient. The ACCTION enhances the opportunity to treat more patients within the local community through collaborative practice with the Tulane Cancer Center faculty. It also provides the local physician with a support system to participate in cutting-edge clinical research trials, which minimizes the impact on office operations while assuring quality and individualized attention for each patient. Through ACCTION, the Tulane Cancer Center serves as the trusted tertiary referral site for complex cases and for patients requiring specialized services not available locally.

With the receipt of this grant funding, the Tulane Cancer Center is in a position to provide the best cancer care possible while sharing its wealth of faculty expertise with our neighboring communities.

The Breast Cancer Fund Fashion Show and Luncheon

On May 8th, more than 400 women and men gathered for the second annual "Tribute to Breast Cancer Survivors and Other Heroes" fashion show and luncheon at the Sheraton Hotel on Canal Street. Hosted by The Breast Cancer Fund, a national non-profit organization devoted to creating awareness and support for cutting-edge programs and research, the event featured 25 models (all breast cancer survivors in various stages of recovery) and their escorts, wearing the latest summer fashions from J.C.Penney, with make-up and coiffures provided by Arthur's House of Glamour. Honored guests included state Senator Diana Bajoie, state Representative Jackie Clarkson, and First Lady of Louisiana Alice Foster, for their commitment and legislation promoting access to breast cancer prevention, diagnosis, and treatment programs. Event chairs Bonnie Broel of the House of Broel and state Senator Paulette Irons staged a first-class show. This year's event beneficiaries were the Tulane Cancer Center, the Louisiana Breast Cancer Task Force, and The Breast Cancer Fund Research Program.

'98 Sports for Life
Teaming Up Against Prostate Cancer

As the summer cooled down the courts heated up on September 19 for the second annual Sports for Life Basketball Tournament and Youth Clinic at the Tulane University Reily Student Recreation Center.

In an effort to increase community awareness of prostate cancer and the importance of annual screening, the Tulane Cancer Center hosted a day filled with 3-on-3 baskelball, shooting contests with celebrity judges, and a health fair for over 250 men, women, and youth participants. In addition to the tournament this year, a Youth Clinic took place for 200 local 8-to-14 year-old boys and girls the evening before, featuring NBA coaches Alvin Gentry (Detroit Pistons) and Brian James (Toronto Raptors), NBA player Jaren Jackson (San Antonio Spurs), Tulane Women's Basketball assistant coaches Amy Wallace and Kellie Kennedy, and Keisha Johnson, Tulane's assistant director of Intramural Sports.

As part of the Sports for Life program, the Tulane Cancer Center Comprehensive Clinic was the site on September 22 and 23 for 225 men to receive a free prostate cancer screening.

Many thanks go out to the sponsors and volunteers of Sports for Life for their continued support and endless hours of hard work to maket his program such a success.

Derrick Beech, M.D. Selected Principal Investigator of P-2 Grant

The Tulane Cancer Center was recently awarded a grant from the National Surgical Adjuvant Breast and Bowel Project (NSABP) to serve as a designated clinical center for the P-2 Protocol: A Study of Tamoxifen and Raloxifine (STAR) for the prevention of breast cancer.

In 1992, the P-1 Study tested the hypothesis that Tamoxifen played a role in breast cancer prevention. The Study's conclusions reported the drug to decrease the incidence of invasive and non-invasive breast cancer. Despite side effects resulting from the administration of Tamoxifen its use as a breast cancer preventitive agent is appropriate for many women at high risk for the disease.

As principal investigator of the P-2 study, Dr. Derrick Beech will oversee this Phase III, double-blind trial that will assign eligible postmenopausal women to either daily Tamoxifen (20mg orally) or Raloxifene (60mg orally) therapy for 5 years. Trial participants will also complete at least two additional years of follow-up after therapy cessation. Since this is a double-blind trial, neither the particpant nor her doctor will know which drug she is taking.

Dr. Beech joined the Tulane Department of Surgery as an Assistant Professor in Surgery after completing his fellowship in Surgical Oncology at the University of Texas, M.D. Anderson Cancer Center in Houston. Originally from Atlanta, he completed his undergaduate studies in mathematics at Duke University in Durham, North Carolina. Dr. Beech attended the Medical College of Virginia in Richmond, receiving numerous honors including induction into the Alpha Omega Alpha Medical Honor Society and Phi Kappa Graduate Honor Societies. It was during this time that he developed an interest in general surgery and surgical oncology. Dr. Beech completed his general surgical residency at Temple University Hospital in Philadelphia before moving to Houston.

While at M.D.Anderson, Dr. Beech focused on the clinical and molecular factors involved in the control of soft tissue sarcoma and colon adenocarcinoma. He developed a keen interest and aptitude in the management of hepatobiliary disease and distal rectal carcinoma. His research interest involved the evaluation of the molecular determinants associated with cancer progression, particularly growth factor receptor modulation in cancer therapy.

"The diagnosis and treatment of breast cancer has made great strides in the last few years," reflects Dr. Beech. Certified by the American Board of Surgery and a member of the American College of Surgeons and the Society of Surgical Oncology, Dr. Beech maintains an interest in TCC community outreach programs directed at heightening awareness of cancer and disease prevention in underserved populations.

According to Dr. Beech, the first and primary aim of the P-2 Protocol will be to determine whether long-term Raloxifene therapy is effective in preventing the occurrence of invasive breast cancer in postmenopausal women who are identified as being at high risk for developing the disease. Those eligible to participate include postmenopausal women over the age of 60, regardless of their risk level for developing breast cancer, and postmenopausal women over the age of 35 whose risk for developing breast cancer is equal to or greater than the risk of a 60-year-old women inthe general population who has no additional risk factors for breast cancer.

22,000 women from across the country will be recruited for this study. Dr. Beech will work within the Tulane University Hospital and Clinic and the Medical Center of Louisiana and with a host of community-based physicians to identify candidates from the Gulf South region, particularly in our minority communities.

A Salute to TCC Members & Friends:
A Sampling of News, Awards, and Accolades
Derrick Beech, M.D.
Appointed Assistant Dean for Student Affairs in the Tulane Univerity School of Medicine.
Rodney Davis, M.D.
One of the leading enrollers for patients in SWOG and other oncology-related protocols.
Prescott Deininger, Ph.D.
Interviewed for the article "Bring in da Noise, Bring in da Junk: The Semantics of Junk DNA", Journal of the National Cancer Institute, 90(15): 1127, August 5, 1998
Melanie Ehrlich, Ph.D.
Chairwoman and participant of the Gordon Research Conference on "DNA Alterations in Transformed Cells: New Insights into the Molecular Genetics of Cancer," Colby-Sawyer College, New Hampshire, August 9-14, 1998. Presentation entitled: "Hypomethylation in pericentromeric DNA vs. global methylation levels in ovarian tumors and in ICF, a pericentromeric chromosomal rearrangement-prone disease."
Griselda Gutnisky, M.D.
David Jansen, M.D.; M.R.Murphy; S. Alliabadi-Wahle, John Ferrara, M.D.
Laparscopic Repair of an Abdominal Wall Hernia after TRAM Flap Reconstruction of the Breast, Plastic and Reconstructive Surgery, 102(5): 1623-1625, October 1998
Marc Kahn, M.D.
Recipient of the 1998 Owl Club Honor Roll Award for Second Year Teaching
(Award selected by the Tulane Medical School student body.)
Robert Kuske, M.D.
Recipient of the 1998 Woodward & White's Best Doctors in America designation.
Wai-Choi Lueng, Ph.D.
invited speaker for the 1998 Workshop on "Beyond the Identification of Transcribed Sequences: Functional and Expression Analysis," Vienna, Virginia, October 24-26, 1998.
Laura Levy, Ph.D.
Invited participant and coordinator of the NCI Workshop on Animal Models of AIDS-Related Lymphoma, August 17-18, 1998, Emory University School of Medicine, Atlanta, Georgia. Title of talk: "Presentation of the Tulane experience: Lymphomagenesis in an SIV-Infected Rhesus Model."
Alan Miller, Ph.D., M.D.
Raja Mudad, M.D.
Recipient of the 1998 Tulane Residency Program Outstanding Teaching Award (for the second year in a row.)
Joyce Parker-Osum, R.N.
Recipient of the Oncology Nursing Foundation's Pearl Moore Career Development Award.
W.R.Robinson, M.D.
Recipient of the Gynecologic Cancer Foundation's 1998 President's Award given for the outstanding paper presented at the 29th Annual Meeteing of the Society of Gynecologic Oncologists, entitled, "Vaccine Therapy for Ovarian Cancer Using Herpes Simplex Virus-Thymidine Kinase (HSV-TK) Suicide Gene Transfer Technique: A Phase I Trial".
Raju Thomas, M.D.
Roy Weiner, M.D.
Ellen Zakris, M.D.


INSIDE THE TULANE CANCER CENTER
 Your Partner for Life!
 Editorial Staff & Contacts
EDITORIAL
Editor: DR. ROY S. WEINER
News & Features Editor: ANGELA M. LATINO
Art/Production: STEVEN D. PIERRE

How to Contact Us

Tulane Cancer Center
(504) 988-6060
(504) 988-6077 fax
Box SL-68, 1430 Tulane Ave., New Orleans, LA 70112-2699, USA
WWW homepage: http://www.som.tulane.edu/cancer

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(504) 988-2120
WWW homepage: http://www.som.tulane.edu/cancer/friedler.html

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WWW homepage: http://www.tuhc.com

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WWW homepage: http://www.tuhc.com


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