• Bone Marrow Transplantation Program.

  Cesar Freytes, M.D., Director of the UTHSCSA BMT Program and of the BMT Program at the South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division; Natalie Callander, M.D., Director of the BMT Program at University Hospital; Yair Gazitt, Ph.D., Director, BMT Laboratory at UTHSCSA; BMT Fellows.
  
  The UTHSCSA BMT Program was established in 1984. Currently there are BMT units in both University Hospital (6 beds) and the Audie Murphy Hospital (8 beds). Health Science Center faculty also have transplant admitting privileges at the Methodist Hospital BMT facility. During the 1998/1999 academic year 86 bone marrow transplant procedures were performed at UTHSCSA (55 at ALMVAH and 31 at UH). The ALMVAH BMT Program is one of only three VA BMT programs nationwide and therefore is a national referral center.

  Research foci of the BMT Program are in the areas of multiple myeloma, lymphoma, myelofibrosis, and supportive care. Active clinical BMT studies include the following:

   

  1. A prospective study to evaluate the performance and complications of vascular access devices in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation. (C. Freytes, co-investigator)
  2. Double-blind, Randomized, Multicenter Trial Comparing 2 Schedules of CGP 46614 and placebo to prevent/alleviate chemotherapy induced oral mucositis in patients with lymphoma, cancer of the breast or other solid tumors, who receive preparatory chemotherapy for autologous bone marrow transplantation or stem cell transfusion. (C. Freytes, co-investigator)
  3. Phase I/II Dose Escalation of Trial of Paclitaxel Incorporated into High-Dose Cyclophosphamide, Carmustine (BCNU), and Etoposide Phosphate (VP-16 Phosphate) (CBV) with Autologous Bone Marrow or Peripheral Stem Cell Support in Patients with Relapsed, Refractory or High Risk Hodgkinís Disease or Non-Hodgkin's Lymphoma. (C. Freytes, PI) 4) Randomized Study of Peripheral Blood Stem Cell Mobilization with Cyclophosphamide in Combination with G-CSF GM-CSF, or sequential GM-CSF Followed by G-CSF in Non-Hodgkin's Lymphoma Patients. (N. Callander and Y. Gazitt, Co-PIs) 5) A Pilot Study of the Effect of Pamidronate on Peripheral Stem Cell Mobilization in Patients Undergoing Autologous Bone Marrow Transplant for Multiple Myeloma. (N. Callander and Y. Gazitt, co-PIs)
  4. A Randomized Double-blind Study of Low Dose vs. Standard Dose Filgrastim (G-CSF) Following Auto Peripheral Blood Stem Cell Transplantation. (N. Callander, PI)
  5. Phase II Study Using Single Agent Paclitaxel And G-CSP For Autologous Peripheral Blood Stem Cell Mobilization. (T. Tsai, PI)
  6. A Prospective Randomized Phase III Study Using CEPRATE’ SC Stem Cell Concentrator to Concentrate Hematopoietic Progenitors For Use in Hematopoietic Support After High Dose Chemotherapy. (C. Freytes, co-investigator)
  7. A Multicenter Randomized Double Blind Trial of Enoxaparan Versus Placebo For Prevention of Hepatic Veno-Occlusive Disease Following Hematopoietic Stem Cell Transplantation (N. Callander, PI)
  8. Multicenter Phase II Study of Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis. (J. Anderson, PI)

   

• Anti-Coagulation Clinic

The Division of Hematology administers the Anticoagulation Clinic (ACC) located at the University Health Center Downtown. The Anticoagulation clinic is under the direction of Dr. Callander.  A Pharm.D. experienced in the care of chronically anticoagulated patients, oversee the on-site management of the clinic. A medical record-quality electronic progress note system permits documentation by physicians of daily patient encounters and close supervision of the clinic's operation by the Hematology physicians from the HSC campus. A comprehensive research database has been developed with the help of the UH Division of Information Services and is being implemented. The clinic currently follows 300 patients, evaluates 15 patients daily and receives 10 new consults per month from all in-patient services and UTHSCSA out-patient facilities. The clinic refers cases to the Hematology Clinic for consultation by the fellows and residents and serves as a teaching resource for Pharm. D. students who do 6 week rotations there.

• Multiple Myeloma Bone Disease Program

A multidisciplinary Multiple Myeloma Program  was developed during the 1996-1997 academic year. The University of Texas Health Science Center at San Antonio is uniquely positioned to develop a Myeloma Program that focuses on myeloma bone disease, with major resources already in place to contribute to this effort. Such a program meets an important need in myeloma research, the coupling of bone cell biology to treatment of myeloma. Bone destruction in myeloma patients is the major source of morbidity. These bony lesions do not heal even after bone marrow transplantation or intensive chemotherapy. The focal point of the program is a multidisciplinary clinic which meets every Monday morning in the GCRC at the ALMVAH. To date, approximately 100 patients have been evaluated in the clinic and approximately 80 are being followed on a regular basis. All patients are enrolled in a longitudinal cytokine protocol to study levels of relevant cytokines in circulation over time. Also patients donate bone marrow cells and plasma to a myeloma repository. Several clinical protocols also are available for patient enrollment. These include the following:

1. Double blind, randomized, dose ranging safety and efficacy trial of rapid intravenous infusion of zoledronate vs. aredia in cancer patients with osteolytic bone metastases - Phase II. (N. Callander, PI)
2. A pilot study of the effect of pamidronate on peripheral stem cell mobilization in patients undergoing autologous bone marrow transplantation for multiple myeloma. (N. Callander and Y. Gazitt, co-PIs)
3. A study of molecular mechanisms of melphalan induced apoptosis in multiple myeloma cells. (Y. Gazitt, PI)
4. A Phase II trial of gemcitabine and paclitaxel for patients with relapsed and refractory multiple myeloma. (Y. Gazitt, PI)
5. Phase II trial of gemcitabine and paclitaxel for patients with relapsed and refractory multiple myeloma. (Y. Gazitt)
6. Development of a systemic delivery of adenovirus-p53-based therapy for the treatment of refractory multiple myeloma patients. (Y. Gazitt)

 

• Other Hematology Clinical Protocols

A Randomized Controlled Trial of Mitoxantrone and Etoposide Versus Daunomycin and Cytosine Arabinoside As Induction Therapy in Patients Over Age 55 With Previously Untreated Acute Myeloid Leukemia, Phase III. SWOG 9333. 

A Phase I Study of PSC833 as Chemotherapy-Resistance Modifier in Patients Over Age 45 With Previously Untreated Acute Myeloid Leukemia (AML). SWOG 9617. 

A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Recombinant Human CD40 Ligand (rhu CD40L) in Cancer Patients. 

Sequential Antithymocyte Globulin and Amifostine for the Treatment of Myelodysplastic Syndrome. 

Pivotal Phase III Multicenter Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C 2B8 (IDEC-102) in Patients With Low Grade or Follicular B-Cell Lymphoma. (C. Freytes, Co-Investigator)

Treatment of Adult Acute Lymphoblastic Leukemia: A Phase II Trial of an Induction Regimen Including PEG-L-Asparaginase in Previously Untreated Patients Followed by Allogeneic Bone Marrow Transplantation or Further Chemotherapy in First Complete Remission. SWOG 9400 (D. Boldt, co-coordinator)

A Phase II Study of High Dose Cyclophosphamide Followed by Fludarabine in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia. SWOG 9706 (D. Boldt, co-coordinator)

A Phase II Study of IL-4 in Patients With B-Lineage ALL in First or Second Relapse. SWOG 9711 (D. Boldt, co-coordinator)

A Phase II Study of ìCPT-11 (Irinotecan) in patients with refractory or relapsed chronic lymphocytic leukemia (CLL)î (J. Anderson, PI) A Phase II, open-label, multicenter, randomized, comparative study of topotecan, ara-C, G-CSF versus idarubicin, ara-C, G-CSF in MDS patients with RAEB (high-risk), RAEB-T, or in patients with AML from a preceding phase of MDSî (SmithKline Beecham sponsored)