NCI CTEP-Approved Trials for the Month of August

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The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.


Phase I

9571: A Phase IB Study of the Combination of AZD6244 Hydrogen Sulfate (Selumetinib) and Cyclosporin A (CsA) in Patients with Advanced Solid Tumors with an Expansion Cohort in Metastatic Colorectal Cancer. University of Texas MD Anderson Cancer Center; LAO Lieu, Christopher Hanyoung. (303) 724-6390


Phase I/II

9577: Phase 1 Study of Ibrutinib and Immuno-Chemotherapy Using Dose-Adjusted-Temozolomide, Etoposide, Doxil, Dexamethasone, Ibrutinib, Rituximab (DA-TEDDI-R) in Primary CNS Lymphoma. NCI Lymphoid Malignancies Branch; Dunleavy, Kieron Michael. (301) 435-1007


Phase II

9568: A Randomized Placebo-Controlled Phase II Trial Comparing Gemcitabine Monotherapy to Gemcitabine in Combination with AZD 1775 (MK 1775) in Women with Recurrent, Platinum Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers. University Health Network-Princess Margaret Hospital; Oza, Amit M. (416) 946-2818

NRG-LU001: Randomized Phase II Trial of Concurrent Chemoradiotherapy Metformin HCL in Locally Advanced NSCLC. NRG Oncology; Tsakiridis, Theodoros. (905) 387-9495

S1314: A Randomized Phase II Study of CO-eXpression ExtrapolatioN (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer. SWOG; Flaig, Thomas W. (303) 724-3888

S1406: Randomized Phase II Study of Irinotecan and Cetuximab with or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer. SWOG; Kopetz, Edmund Scott. (713) 792-2828


Phase III

ANBL1232: Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma. Children’s Oncology Group; Meany, Holly J. (202) 476-2800

E4512: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein. ECOG-ACRIN Cancer Research Group; Gerber, David Eric. (214) 648-4180

S1316: Prospective Comparative Effectiveness Trial for malignant Bowel Obstruction. SWOG; Krouse, Robert Scott. (520) 626-4703


Pilot Phase

9622: A Pilot Study of 18F-DCFBC PET/CT in Prostate Cancer. National Cancer Institute Molecular Imaging Program; Lindenberg, Maria Liza. (301) 443-0604


Other Phases

A151216: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST). Alliance for Clinical Trials in Oncology; Janne, Pasi Antero. (617) 632-6076

AALL13B5-Q: Development and Implementation of a Novel Prognostic Test in ALL. Children’s Oncology Group; Miles, Rodney R. (801) 213-3448

ACNS14B1-Q: STAT3 Signaling in Medulloblastoma. Children’s Oncology Group; Lin, Jiayuh. (614) 722-5086

AEWS13B3-Q: Investigating G-Protein Coupled Receptors (GPCRs) as Biomarkers of Aggressive Disease and Novel Therapeutic Targets in Ewing Sarcoma. Children’s Oncology Group; Lawlor, Elizabeth Rachel. (734) 615-4814

ANBL14B2-Q: The Role of CIP75 as an Oncogene in Childhood Neuroblastoma. Children’s Oncology Group; Barlos, Vivian. (808) 956-2712

ANBL14B3-Q: Prevalence and Clinical Correlations of Somatostatin Receptor-2 (SSTR2) Expression in Neuroblastoma. Children’s Oncology Group; Baruchel, Sylvain. (416) 813-7795

E2993T6: Role of Ikaros in the Biology and Therapy of High-Risk Precursor B-Cell Leukemia. ECOG-ACRIN Cancer Research Group; Van Etten, Richard A. (949) 824-2655

EA914LT2: Genetic Analyses of Relapsed ALL. ECOG-ACRIN Cancer Research Group; Ferrando, Adolfo A. (212) 851-4611

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