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

9782: A Phase 1 Study of BMN 673 in Combination with Carboplatin and Paclitaxel in Patients with Advanced Solid Tumors. Rutgers University – Cancer Institute of New Jersey LAO; Wisinski, Kari Braun. (608) 263-6222

9824: A Phase 1 Study of Alisertib (MLN8237) in Combination with mFOLFOX in Gastrointestinal Tumors. Yale University Cancer Center LAO; Goff, Laura Williams. (615) 322-4967

9853: A Phase 1 Study of AZD1775 in Combination with Belinostat in Relapsed and Refractory Myeloid Malignancies and Selected Untreated Patients with Acute Myeloid Leukemia. Moffitt Cancer Center P2C; Shafer, Danielle Aimee. (804) 628-0279

Phase II

9742: Multicenter Phase II Study of Nivolumab in Previously Treated Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma. Mayo Clinic Cancer Center P2C; Ma, Brigette Buig-Yue. 852- 26322118

A091401: Randomized Phase II Study of Nivolumab with or Without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma. Alliance for Clinical Trials in Oncology; D’Angelo, Sandra Pierina. (646) 888-4159

Phase III

A061402: Solitary Plasmacytoma of Bone: Randomized Phase III Trial to Evaluate Treatment with Adjuvant Systemic Treatment and Zoledronic Acid Versus Zoledronic Acid After Definite Radiation Therapy. Alliance for Clinical Trials in Oncology; Mahindra, Anuj Kumar. (415) 476-9492

S1404: A Phase III Randomized Trial Comparing High Dose Interferon to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma. SWOG; Grossmann, Kenneth F. (801) 587-4289

URCC-14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors. University of Rochester NCORP Research Base; Mustian, Karen M. (585) 275-5513

Other Phases

A151432: Homologous Recombination Deficiency Biomarker to Predict pCR with Platinum-Based Therapy in Patients with Triple Negative Breast Cancer Treated on CALGB 40603. Alliance for Clinical Trials in Oncology; Carey, Lisa A. (919) 966-4431

A221405: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy. Alliance for Clinical Trials in Oncology; Partridge, Ann Hart. 617-632-2335

ABTR14B3-Q: Immunogenomics to Create New Therapies for High-Risk Childhood Cancers. Children’s Oncology Group; Sorensen, Poul Henrik Bredahl. (604) 875-2936

AEWS15B4-Q: Evaluation of ctDNA as a Diagnostic and Prognostic Tool in Ewing Sarcoma. Children’s Oncology Group; DuBois, Steven G. (415) 476-4764

ANBL14B7-Q: Preliminary Studies of Circulating GD2 as a Predictive Biomarker in Neuroblastoma NBL. Children’s Oncology Group; Desai, Ami V. (267) 207-5032

ANBL15B1-Q: EphB4 and EphrinB2 as Therapeutic Targets in Neuroblastoma. Children’s Oncology Group; Keller, Charles. (503) 494-1210

C10403T1: Correlation of Minimal Residual Disease (MRD) with Treatment Outcomes in Adolescents and Young Adults with Acute Lymphoblastic Leukemia : Results of US Intergoup Trial C-10403. ECOG-ACRIN Cancer Research Group; Stock, Wendy. (773) 834-8982

CLC.2E: A Prospective Economic Analysis of NCIC CTG CLC.2/Alliance A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) with Chronic Lymphocytic Leukemia (CLL). NCIC Clinical Trials Group; Cheung, Matthew. (416) 480-4928

S0016C: Quantifying Genetic Diversity in Follicular Lymphoma to Predict Disease Progression. SWOG; Burack, W. Richard (585) 276-1885

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