Clinical Trials
A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects with Hematological Malignancies
Lead Researcher: Paul M Barr
This is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of VLS-101, an antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1) on cancer cells. The study is evaluating VLS-101 in patients with previously treated hematological cancers.
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EA4151 ~ Phase III Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
Lead Researcher: Paul M Barr
This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.
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Phase II study of acalabrutinib and high frequency low dose subcutaneous rituximab in patients with previously untreated CLL/SLL,Phase II study of acalabrutinib and high frequency low dose subcutaneous rituximab in patients with previously untreated CLL/SLL
Lead Researcher: Paul M Barr
The main purpose of this research study is to find out if the combination of acalabrutinib and high frequency low dose subcutaneous rituximab is safe and effective in patients who have previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
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CMT18023: Treatment with Ipilimumab and Nivolumab for Rare Cancers,CMT18023: Treatment with Ipilimumab and Nivolumab for Rare Cancers
Lead Researcher: Paul M Barr
This phase II trial studies nivolumab and ipilimumab in treating patients with rare tumors. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
This trial enrolls participants for the following cohorts based on condition:
Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal, nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN]) B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx (closed to accrual 07/27/2018)
Epithelial tumors of major salivary glands (closed to accrual 03/20/2018)
Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location (closed to accrual)
Undifferentiated carcinoma of gastrointestinal (GI) tract
Adenocarcinoma with variants of small intestine (closed to accrual 05/10/2018)
Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas) (closed to accrual 10/17/2018)
Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary (closed to accrual 03/20/2018)
Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma. Pancreatic adenocarcinoma is not eligible
Intrahepatic cholangiocarcinoma (closed to accrual 03/20/2018)
Extrahepatic cholangiocarcinoma and bile duct tumors (closed to accrual 03/20/2018)
Sarcomatoid carcinoma of lung
Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma
Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor and adenosarcoma (closed to accrual 03/30/2018)
Trophoblastic tumor: A) Choriocarcinoma (closed to accrual)
Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder (closed to accrual)
Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation (closed to accrual)
Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis
Squamous cell carcinoma variants of the genitourinary (GU) system
Spindle cell carcinoma of kidney, pelvis, ureter
Adenocarcinoma with variants of GU system (excluding prostate cancer) (closed to accrual 07/27/2018)
Odontogenic malignant tumors
Pancreatic neuroendocrine tumor (PNET) (formerly named: Endocrine carcinoma of pancreas and digestive tract.) (closed to accrual)
Neuroendocrine carcinoma including carcinoid of the lung (closed to accrual 12/19/2017)
Pheochromocytoma, malignant (closed to accrual)
Paraganglioma (closed to accrual 11/29/2018)
Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex (closed to accrual)
Desmoid tumors
Peripheral nerve sheath tumors and NF1-related tumors (closed to accrual 09/19/2018)
Malignant giant cell tumors
Chordoma (closed to accrual 11/29/2018)
Adrenal cortical tumors (closed to accrual 06/27/2018)
Tumor of unknown primary (Cancer of Unknown Primary; CuP) (closed to accrual 12/22/2017)
Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC cohort, contact: S1609SC@swog.org] (closed to accrual 03/15/2019)
Adenoid cystic carcinoma (closed to accrual 02/06/2018)
Vulvar cancer (temporarily closed to accrual)
MetaPLASTIC carcinoma (of the breast) (closed to accrual)
Gastrointestinal stromal tumor (GIST) (closed to accrual 09/26/2018)
Perivascular epithelioid cell tumor (PEComa)
Apocrine tumors/extramammary Paget's disease (closed to accrual)
Peritoneal mesothelioma (temporarily closed to accrual 05/08/2020)
Basal cell carcinoma (temporarily closed to accrual 04/29/2020)
Clear cell cervical cancer
Esthenioneuroblastoma (closed to accrual)
Endometrial carcinosarcoma (malignant mixed Mullerian tumors) (closed to accrual)
Clear cell ovarian cancer (closed to accrual)
Gestational trophoblastic disease (GTD)
Gallbladder cancer
Small cell carcinoma of the ovary, hypercalcemic type
PD-L1 amplified tumors
Angiosarcoma
High-grade neuroendocrine carcinoma (pancreatic neuroendocrine tumor [PNET] should be enrolled in Cohort 22; prostatic neuroendocrine carcinomas should be enrolled into Cohort 52). Small cell lung cancer is not eligible (temporarily closed to accrual 03/25/2020)
Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
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ILYM17064: Phase I/II study of venetoclax in combination with Ublituximab and Umbralisib (TGR-1202) in patients with relapsed or refractory CLL/SLL
Lead Researcher: Paul M Barr
Phase I/II Study of Venetoclax or Lenalidomide in Combination with Ublituximab and Umbralisib in Subjects with Relapsed or Refractory CLL/SLL and NHL
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S1608:Testing two new targeted drug combinations against standard chemotherapy for early relapsing or refractory follicular lymphoma
Lead Researcher: Paul M Barr
This phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
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Publications
Journal Articles
12/1/2020
Mato AR, Ghosh N, Schuster SJ, Lamanna N, Pagel JM, Flinn IW, Barrientos J, Rai KR, Reeves JA, Cheson BD, Barr PM, Kambhampati S, Lansigan F, Pu JJ, Skarbnik AP, Roeker LE, Fonseca G, Sitlinger A, Hamadeh IS, Dorsey C, LaRatta N, Weissbrot H, Luning Prak ET, Tsao PY, Paskalis D, Sportelli P, Miskin HP, Weiss MS, Svoboda J, Brander DM. "Phase 2 Study of the Safety and Efficacy of Umbralisib in Patients with CLL Who Are Intolerant to BTK or PI3K? Inhibitor Therapy." Blood.. 2020 Dec 1; Epub 2020 Dec 01.
10/30/2020
Zent CS, Brady MT, Delage C, Strawderman M, Laniewski N, Contant PN, Kanagaiah P, Sangster MY, Barr PM, Chu CC, Topham DJ, Friedberg JW. "Short term results of vaccination with adjuvanted recombinant varicella zoster glycoprotein E during initial BTK inhibitor therapy for CLL or lymphoplasmacytic lymphoma." Leukemia.. 2020 Oct 30; Epub 2020 Oct 30.
10/25/2020
Rodgers TD, Williams AM, Baran A, Reagan PM, Casulo C, Zent CS, Evans A, Friedberg JW, Barr PM. "Toxicity patterns of novel PI3K combinations in patients with non-Hodgkin lymphoma." Leukemia & lymphoma.. 2020 Oct 25; :1-8. Epub 2020 Oct 25.
Books & Chapters
2019
Book Title: How I treat early relapsing follicular lymphoma
Author List: Casulo C, Barr PM
Published By: Blood 2019
2019
Book Title: Augmenting Indolent Lymphoma Treatment Options with the Combination of Lenalidomide and Rituximab.
Author List: Barr PM
Published By: J Clin Oncology 2019
2018
Book Title: COUNTERPOINT: Can Chemotherapy Be Eliminated in the Treatment of Follicular Lymphoma?
Author List: Barr PM
Published By: Oncology 2018
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