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Translational Research subjects promising cancer therapies to early stage "proof of concept" trials. The initial trials are focused on developing ways to enhance the ability of the natural immune system to recognize and eliminate tumor cells. Trials to test this concept in the following diseases have now been approved by the Institutional Review Board at the Abramson Cancer Center at the University of Pennsylvania.
The listing that follows is a representative sample of currently open trials and is subject to change. Please check with the listed investigators for more information.
Lymphoma
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UPCC 05402:
A Feasibility/Phase I Study of Fludarabine-Cyclophosphamide with Immune System Support Using CD25 Depleted and CD3/CD28 Ex Vivo Costimulated Autologous T Cells in Patients with Previously Treated Relapsed/Refractory Follicular Non- Hodkin's Lymphoma.
Patients with previously treated, relapsed, or refractory Follicular Non-Hodgkin's Lymphoma (grade I and II) who have not received previous treatment with purine analogs (such as fludarabine) may be eligible for this open-label feasibility/phase I study. Patients will undergo combination chemotherapy with four cycles of cyclophosphamide-fludarabine. Those who achieve a complete or partial response four weeks after last chemotherapy will then receive an infusion of CD25-depleted, CD3/CD28-costimulated autologous T cells (collected and ex vivo expanded from cells collected prior to the start of the chemotherapy) to test whether this combination strategy can enhance immune reconstitution and improve disease control. (Physician contact: Stephen Schuster, M.D.)
Study nurse: Kathleen Wiley, RN, BSN 215-668-4712 |
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UPCC 15406: Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR? and 4-1BB Signaling Domains in Patients with Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma.
For individuals for CD19 positive B cell lymphoma a clinical trial is in development expected to open in mid 2007. This is a pilot study for people who have been previously treated for B cell Leukemia/Lymphoma. This is a new approach to treatment of Leukemia/Lymphoma that involves genetic modification of T cells in a way that allows them to recognize B cells and eliminate them. Volunteers include male and female patients with documented CD19-positive B cell tumors, who have been previously treated for their cancer. (Physician Contact: David Porter, M.D.)
Study nurse: Adri Recio, RN 215-573-6760 |
Leukemia
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UPCC 08405:
Non-Myeloablative Conditioning with Allogeneic Peripheral Blood Progenitor Cell Transplantation Followed by Prophylactic Activated Donor Lymphocyte Infusion (DLI) for the Treatment of High Risk Acute Leukemia/MDS.
Patients with high risk Acute Myelogenous or Acute Lymphoblastic Leukemia in first or second complete remission who are ineligible for or unwilling to undergo a traditional allogeneic stem cell transplant may be eligible for this feasibility/phase I study. Patients will first receive fludarabine/busulfan in combination with Campath (alemtuzumab) as non-myeloablative conditioning with allogeneic progenitor cell transplantation. This regimen will be followed by prophylactic CD3/CD28-costimulated T cells from a donor to test for induction of a graft versus leukemia effect. (Physician contact: Stephen Goldstein, M.D.)
Nurse Practitioner: Jackie Smith, MSN, CRNP 215-614-1884 |
Myeloma
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UPCC 13406:
Phase I/II Combination Immunotherapy after ASCT for Advanced Myeloma to Study HTert Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells.
Patients with systemic or multifocal myeloma requiring autologous stem cell transplantation, and who have relapsed or only partially responded to prior treatment or have high risk features may be eligible for this combination immunotherapy phase I/II study. Based on HLA-A2 status (+ or 1), patients will be randomized to two separate arms. All patients will receive high dose chemotherapy, stem cell transplantation, and an infusion of vaccine-primed CD3/CD28-costimulated autologous T cells. The two patient arms differ in the vaccine immunizations that will be given to them prior to the T cell collection and three other times after the T cell infusion. Patients will either be provided with the pneumococcal vaccine alone or the pneumococcal vaccine in combination with an experimental hTERT multipeptide vaccine. At 6 months post-transplant, all patients will be started on maintenance thalidomide. (Physician contact: Edward Stadtmauer, M.D.)
Study nurse: Denise Bendig, RN, BSN 215-746-3637 |
Ovarian Cancer
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UPCC 01803:
Randomized Phase I/II Pilot Study of the Immunogenicity of Cyclophosphamide with Peptide Pulsed Mature Dendritic Cells for Patients with Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma.
For individuals with previously treated ovarian cancer and have no evidence of disease, there is an ongoing phase I/II study evaluating an autologous dendritic cell vaccine that is designed to target tumor antigens that are commonly present in ovarian tumors. This trial has two arms to which the patient is randomly assigned, one includes treatment with cyclophosphamide and one does not. The trial is evaluating whether inclusion of cyclophosphamide improves responses to vaccine, and evaluates progression free survival. (Physician Contact: Christina Chu, M.D.).
Study nurse: Denise Bendig, RN, BSN 215-746-3637 |
HIV
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HIV STI IRB Protocol #704671:
A Phase I/II Open Label, Single enter Study to Evaluate the Tolerability, Trafficking and Therapeutic Effects of Repeated Doses of Autologous T Cells Transduced with VRX496 in HIV Infected Subjects.
VRX496 is an HIV-based lentiviral vector containing an anti-HIV antisense sequence targeted to the HIV envelope (env) coding sequence. In this trial, T cells will be harvested from infected individuals, transduced (genetically modified) ex vivo (outside the body) with the vector, and then reintroduced by intravenous transfusion. Subjects will receive up to 6 infusions of VRX496 modified CD4 T cells, and then undergo a series of tests, including rectal mucosal biopsies, to determine the longevity and trafficking of the VRX496 T cells. In addition, subjects will have the opportunity to have a supervised drug holiday (structured treatment interruption) to determine if VRX496 has an antiviral effect. (Physician Contact: Pablo Tebas, M.D.)
http://www.clinicaltrials.gov/ct/show/NCT00295477?order=1.
Study nurse: Larisa Zifchak, RN 215-349-8091 |
Neuroblastoma
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CHP 667:
A Pilot Study of Tandem High Dose Chemotherapy with Stem Cell Rescue and T Cell Augmentation in Children with High Risk Neuroblastoma.
In collaboration with the Children's Hospital of Philadelphia, we are conducting a two step trial that involves a first step of standard chemotherapy treatment and surgery for tumor treatment, and a second step of high dose chemotherapy with stem cell and T cell rescue. (Physician Contact: Stephan Grupp, M.D. )
Nurse Practitioner : Marrisa Kuba, RN, CRNP 215-267-426-2384 |
Persistent Malignancy after ASCT
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UPCC 20406:
A Phase I/II Trial of DLI and Activated DLI (ADLI) Followed by Either Repetitive Dosing of aDLI or Dose Escalated ADLI for Patients with Relapse after Allogeneic Stem Cell Transplantation.
Patients with relapsed or persistent malignancy diseases after allogeneic stem cell transplantation whose original HLA-matched donor is available may be eligible for this phase I/II study. This is a two arm dose escalation trial, with assignment based on response to an initial treatment of standard unstimulated T cells from a donor (DLI) followed by CD3/CD28 stimulated T cells from a donor (aDLI). Patients with no response to the initial treatment regimen will be given a higher dose, and patients who go into remission will be given a repetitive dose (“boosters”) of the aDLI. (Physician contact: David Porter, M.D.)
Study nurse: Denise Bendig, RN, BSN 215-746-3637 |
To learn more about cancer clinical trials at the University of Pennsylvania and about participating in a trial, visit Oncolink - Clinical Trials Information.
To learn more about cancer clinical trials, visit Cancer Trial: A service of the National Cancer Institute. |
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