Phase 1 - UM Implemented Tite-CRM Trials

Phase I trials designed and implemented at the University of Michigan Cancer Center that use the TITE-CRM approach.

UMCC 2011.105
A Phase I Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer.  (This trial was opened in 2012 and currently has 2 patients enrolled and with 1 still on treatment).
PI: Mark Zaulpski
Statistician: Kent Griffith

UMCC 2011.087
A Phase 1 Study of Veliparib Administered Concurrently with Chest Wall and Nodal Radiation Therapy in Patients with Inflammatory or Loco-regionally Recurrent Breast Cancer. 
PI: Reshma Jagsi, Lori Pierce
Statistician: Kent Griffith

UMCC 2011.008
A Multi-institutional Phase I and Biomarker Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer
PI: Daniel Hamstra
Statistician:  Stephanie Daignault

UMCC 2009.056
Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment with Carfilzomib, Lenalidomide and Dexamethasone (CRD) in Subjects with Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Systemic Chemotherapy.
PI: Andrzej Jakubowiak  
Statistician: Kent Griffith

UMCC 2008.061 (NCI protocol 8131)
A Phase 1/2 Study of Doxorubicin and A12 (Cixutumumab) in Advanced Soft Tissue Sarcoma. 
PI: Rashmi Chugh, Scott Schuetze
Statistician: Kent Griffith

UMCC 2008.042
A Phase I/II Clinical Trial of intravenous (IV) Calcitriol with fixed dose of Cisplatin and Docetaxel in Advanced Non-Small Cell Lung Cancer.
PI: Nithya Ramnath
Statistician: Jeremy Taylor

UMCC 2007.120
A Phase 1 Study of Alemtuzumab in Patients with Relapsed Ovarian/Primary Peritoneal Cancer.
PI: Ron Buckanovich
Statistician: Kent Griffith

UMCC 2007.098
A Multi-Institutional Phase I/II Study of Revlimid (lenalidomide), Velcade (bortezomib), Dexamethasone, and Doxil, (RVDD) Combination Therapy for Patients with Newly Diagnosed Multiple Myeloma. 
PI: Andrzej Jakubowiak
Statistician: Kent Griffith

UMCC 2007.055
Phase I/II Study of Myeloablative Allogeneic Stem Cell Transplantation for Aggressive Hematologic Malignancies using Clofarabine and Busulfan x 4 (Clo/BU4) regimen
PI: John Magenau
Statistician: Thomas Braun
UMCC 2006.119
Phase I/II Trial of MK-0752 Followed by Docetaxel in Locally Advanced or Metastatic Breast Cancer: A Study by the Stem Cell Clinical Consortium. 
PI: Anne Schott
Statistician: Kent Griffith

UMCC 2006.084
A phase I study of intravenous Irinotecan and Bortezomib in children with recurrent/refractory high-risk neuroblastoma.
PI: Rajen Mody
Statistician: Lili Zhao

UMCC 2006.047
A Phase 1 study evaluating VELCADE as a radiosensitizer in patients with metastatic melanoma to the brain who require while brain radiation.
PI: Bruce Redman
Statistician: Dan Normolle

UMCC 2006.045
Phase 1 study of radiosensitization using bortezomib in patients with relapsed non-hodgkin lymphoma receiving radioimmunotherapy.
PI: Rebecca Elstrom
Statistician: Thomas Braun

UMCC 2006.026
A Phase I Study of Suberoylanilide Hydroxamic Acid (Vorinostat) (NSC 701852) in Combination with Docetaxel in Patients with Advanced and Relapsed Solid Malignancies.
PI:  Bryan Schneider         
Statistician:  Stephanie Daignault and Rodney Dunn

UMCC 2006.018
A Phase I/II radiation dose-escalation study of intensity-modulated radiotherapy (IMRT) with concurrent gemcitabine in patients with unresectable pancreatic cancer
PI: Mark Zalupski
Statistician: Dan Normolle

UMCC 2003.073
A Phase I/II randomized trial in radiation dose escalation and timing of concurrent chemotherapy for patients with unresectable non-small cell lung carcinoma.
PI: Spring Kong
Statistician: Dan Normolle

UMCC 3-23
Phase I study of concurrent gemcitabine and radiotherapy (RT) for malignant high grade gliomas.
PI: Christina Tsien
Statistician: Dan Normolle

UMCC 2-73
A Phase I/II trial of OSI-774 in patients with recurrent malignant gliomas and malignant gliomas post radiation therapy.
PI: Larry Junck

UMCC 2-66
Phase I study of concurrent temozolomide and 3D conformal radiotherapy dose escalation for treatment of primary glioblastoma multiformed.
PI: Howard Sandler
Statistician: Dan Normolle

UMCC 2-14
A Phase I whole liver radiation dose escalation trial using amifostine as a radioprotective agent.
PI: Theodore Lawrence
Statistician: Dan Normolle

UMCC 2-8
Phase I/II trial of dose escalated whole liver irradiation with hepatic arterial floxuridine/leucovorin/streptozotocin chemotherapy followed subsequently by chemoembolization with mitomycin-c for patients with neuroendocrine hepatic metastases.
PI: Neil McGinn
Statistician: Dan Normolle

UMCC 2001-050
Phase I/II evaluation of estramustine and oral vinorelbine on an intermittent schedule in patients with androgen independent prostate cancer (AIPC)
PI: David Smith
Statistician: Rod Dunn

UMCC 2001-044
Phase I/II trial of CCI-779 (NSC#683864) in patients with malignant gliomas
PI: Larry Junck

UMCC 0088
A Phase I study of high dose conformal three-dimensional irradiation in a shortened time interval for medically inoperable stage I lung cancer.
PI: Henning
Statistician: Dan Normolle

UMCC 0084
Phase I study of Hepatic Arterial Yttrium-90 microsphere therapy for primary hepatocellular cancer.
PI: William Ensminger
Statistician: Dan Normolle

UMCC 0045
Phase I study of HSCT in pediatric solid tumors with preparatory regimen of amitostine melphalan carboplatin, etopside & escalating doses of cyclophosphamide.
PI: John Levine
Statistician: external study

UMCC 9976
Phase I trial to escalate does of Cisplatin with Gemcitabine+RT in patients with pancreatic cancer.
PI's: Neil McGinn, Mark Zalupski
Statistician: Dan Normolle

UMCC 9859
A Phase I trial assessing autologous, tumor-pulsed dendritic cells that have been activated by GM-CSF and IL-4 as a tumor vaccine in patients with advanced ovarian cancer.
PI: James Baker
Statistician: Dan Normolle