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
9588: A Phase I Study Combining Ibrutinib with Rituximab, Ifosfamide, Carboplatin, and Etoposide (R-ICE) in Patients with Relapsed or Primary Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Memorial Sloan Kettering Cancer Center; Sauter, Craig S. (212) 639-3460
9849: A Phase I Study of a Continuous Intravenous Infusion of Recomninant Human IL-15 (rhIL-15) in Adults with Metastatic Cancers. NCI Lymphoid Malignancies Branch; Conlon, Kevin C. (301) 402-2913
9850: A Phase I Study of Intravenous Recombinant Human IL-15 (rhIL-15) in Adults with Metastatic Malignant Melanoma and Metastatic Renal Cell Cancer. NCI Lymphoid Malignancies Branch; Waldmann, Thomas Alexander. (301) 496-6656
9851: Haploidentical Donor Natural Killer (NK) Cell Infusion with Intravenous Recombinant Human IL-15 (rhIL-15) in Adults with Refractory or Relapsed Acute Myelogenous Leukemia (AML). University of Minnesota Medical Center-Fairview; Miller, Jeffrey Steven. (612) 624-0123
Phase II
CITN-09: A Phase II Study of MK-3475 in Patients with Advanced Merkel Cell Carcinoma (MCC). Cancer Immunotherapy Trials Network; Nghiem, Paul. (206) 221-2632
CITN-10: A Phase 2 Study of MK-3475 for the Treatment of Relapsed/Refractory Mycosis Fungoides / Sézary Syndrome. Cancer Immunotherapy Trials Network; Kohrt, Holbrook E. K. (650) 723-8222 x 22047
Phase II/III
A071102: A Phase II/III Randomized Trial of Veliparib or Placebo in Combination with Adjuvant Temozolomide in Newly Diagnosed Glioblastoma with MGMT Promoter Hypermethylation. Alliance for Clinical Trials in Oncology; Sarkaria, Jann N. (507) 284-8227
Phase III
A221303: Randomized Study of Early Palliative Care Integrated with Standard Oncology Care Versus Standard Oncology Care Alone in Patients with Incurable Lung or Non-Colorectal Gastrointestinal Malignancies. Alliance for Clinical Trials in Oncology; Temel, Jennifer Gold. (617) 726-2514
AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy). Children’s Oncology Group; Teachey, David Trent. (267) 426-5802
Pilot Phase
9603: Pilot Trial Evaluating Viral Protein Production from the Combination of Reolysin and Carfilzomib in Multiple Myeloma. Ohio State University Medical Center; Hofmeister, Craig C. (614) 293-3507
Other Phases
A151205: Analysis of the Association Between HSP110deltaE9 and Prognosis in Patients with Stage III Colon Cancers with Microsatellite Instability. Alliance for Clinical Trials in Oncology; Goldberg, Richard Miles. (614) 366-6355
ARST14B1-Q: Validation of NRAS, KRAS, HRAS, PIK3CA, BCOR, TP53, NF1, FGFR4, FBXW7, CTNNB1 Mutations in Pediatric Rhabdomyosarcoma. Children’s Oncology Group; Khan, Javed. (301) 439-2937
E1697T1: Quantification of RNA Transcripts of Immune Response Genes in Primary Melanoma Tumors Using NanoString Technology to Establish Prognostic Immune Gene Signature in Patients with Stage II-III Resected Primary Melanoma Tumors. ECOG-ACRIN Cancer Research Group; Saenger, Yvonne. (646) 425-5734
E2404T2: Effect of Somatic RhoA Mutation in Peripheral T Cell Lymphoma (PTCL) on Treatment Outcomes. ECOG-ACRIN Cancer Research Group; Jagadeesh, Deepa. (216) 444-0857
E2993T5: Leukemia Xenografting for Samples From Patients with B-Cell Acute Lymphoblastic Leukemia Enrolled in E2993 Clinical Trial. ECOG-ACRIN Cancer Research Group; Muschen, Markus. (415)502-0388
NRG-CR-TS001: Validation of Predictive Models for the Degree of Benefit From the Addition of Oxaliplatin to Adjuvant FULV in the Treatment of Stage II and III Colon Cancer. NRG Oncology; Pogue-Geile, Katherine. (412) 359-8774
