Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878524
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Oregon Health and Science University
Information provided by (Responsible Party):
Raymond Bergan, MD, OHSU Knight Cancer Institute

Brief Summary:
This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.

Condition or disease Intervention/treatment Phase
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Anatomic Stage IV Breast Cancer AJCC v8 Anemia Ann Arbor Stage III Hodgkin Lymphoma Ann Arbor Stage III Non-Hodgkin Lymphoma Ann Arbor Stage IIIA Hodgkin Lymphoma Ann Arbor Stage IIIB Hodgkin Lymphoma Ann Arbor Stage IV Hodgkin Lymphoma Ann Arbor Stage IV Non-Hodgkin Lymphoma Ann Arbor Stage IVA Hodgkin Lymphoma Ann Arbor Stage IVB Hodgkin Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Castration-Resistant Prostate Carcinoma Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive Hematopoietic and Lymphoid Cell Neoplasm Locally Advanced Pancreatic Adenocarcinoma Metastatic Breast Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Pancreatic Adenocarcinoma Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Primary Myelofibrosis Prognostic Stage IV Breast Cancer AJCC v8 Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive Recurrent Hematologic Malignancy Recurrent Hodgkin Lymphoma Recurrent Myelodysplastic Syndrome Recurrent Myelodysplastic/Myeloproliferative Neoplasm Recurrent Myeloproliferative Neoplasm Recurrent Non-Hodgkin Lymphoma Recurrent Plasma Cell Myeloma Recurrent Small Lymphocytic Lymphoma Refractory Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia Refractory Chronic Lymphocytic Leukemia Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive Refractory Chronic Myelomonocytic Leukemia Refractory Hematologic Malignancy Refractory Hodgkin Lymphoma Refractory Malignant Solid Neoplasm Refractory Myelodysplastic Syndrome Refractory Myelodysplastic/Myeloproliferative Neoplasm Refractory Non-Hodgkin Lymphoma Refractory Plasma Cell Myeloma Refractory Primary Myelofibrosis Refractory Small Lymphocytic Lymphoma Stage II Pancreatic Cancer AJCC v8 Stage IIA Pancreatic Cancer AJCC v8 Stage IIB Pancreatic Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Unresectable Pancreatic Adenocarcinoma Drug: Abemaciclib Drug: Abiraterone Drug: Afatinib Biological: Bevacizumab Drug: Bicalutamide Procedure: Biospecimen Collection Drug: Bortezomib Drug: Cabazitaxel Drug: Cabozantinib Drug: Capecitabine Drug: Carboplatin Drug: Celecoxib Drug: Cobimetinib Drug: Copanlisib Drug: Dabrafenib Drug: Dacomitinib Drug: Darolutamide Drug: Dasatinib Drug: Doxorubicin Biological: Durvalumab Drug: Enzalutamide Drug: Erlotinib Drug: Everolimus Drug: Fluorouracil Drug: Idelalisib Drug: Imatinib Biological: Ipilimumab Drug: Lenvatinib Drug: Leucovorin Drug: Lorlatinib Drug: Losartan Drug: Nab-paclitaxel Drug: Neratinib Biological: Nivolumab Drug: Olaparib Drug: Oxaliplatin Drug: Palbociclib Drug: Panobinostat Biological: Pembrolizumab Biological: Pertuzumab Drug: Ponatinib Other: Quality-of-Life Assessment Drug: Regorafenib Drug: Ruxolitinib Drug: Sirolimus Drug: Sorafenib Drug: Sunitinib Drug: Trametinib Biological: Trastuzumab Emtansine Drug: Tretinoin Drug: Vemurafenib Drug: Venetoclax Drug: Vismodegib Drug: Vorinostat Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : February 27, 2022
Estimated Study Completion Date : February 27, 2025


Arm Intervention/treatment
Experimental: Treatment (biospecimen collection, 2 drug combination)
See Detailed Description.
Drug: Abemaciclib
Given PO
Other Names:
  • LY-2835219
  • LY2835219
  • Verzenio

Drug: Abiraterone
Given PO
Other Name: CB 7598

Drug: Afatinib
Given PO
Other Names:
  • BIBW 2992
  • BIBW2992

Biological: Bevacizumab
Given IV
Other Names:
  • Anti-VEGF
  • Anti-VEGF Humanized Monoclonal Antibody
  • Anti-VEGF rhuMAb
  • Avastin
  • Bevacizumab awwb
  • Bevacizumab Biosimilar BEVZ92
  • Bevacizumab Biosimilar BI 695502
  • Bevacizumab Biosimilar CBT 124
  • Bevacizumab Biosimilar CT-P16
  • Bevacizumab Biosimilar FKB238
  • Bevacizumab Biosimilar HD204
  • Bevacizumab Biosimilar HLX04
  • Bevacizumab Biosimilar IBI305
  • Bevacizumab Biosimilar LY01008
  • Bevacizumab Biosimilar MIL60
  • Bevacizumab Biosimilar QL 1101
  • Bevacizumab Biosimilar RPH-001
  • Bevacizumab Biosimilar SCT501
  • BP102
  • BP102 Biosimilar
  • HD204
  • Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer
  • Recombinant Humanized Anti-VEGF Monoclonal Antibody
  • rhuMab-VEGF
  • SCT501

Drug: Bicalutamide
Given PO
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Procedure: Biospecimen Collection
Undergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)

Drug: Bortezomib
Given IV
Other Names:
  • [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
  • LDP 341
  • MLN341
  • PS-341
  • PS341
  • Velcade

Drug: Cabazitaxel
Given IV
Other Names:
  • Jevtana
  • RPR-116258A
  • Taxoid XRP6258
  • XRP-6258

Drug: Cabozantinib
Given PO

Drug: Capecitabine
Given PO
Other Names:
  • Ro 09-1978/000
  • Xeloda

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Celecoxib
Given PO
Other Names:
  • Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-
  • Celebrex
  • SC-58635
  • YM 177

Drug: Cobimetinib
Given PO
Other Names:
  • Cotellic
  • GDC-0973
  • MEK Inhibitor GDC-0973
  • XL518

Drug: Copanlisib
Given IV
Other Names:
  • BAY 80-6946
  • PI3K Inhibitor BAY 80-6946

Drug: Dabrafenib
Given PO
Other Names:
  • BRAF Inhibitor GSK2118436
  • GSK-2118436
  • GSK-2118436A
  • GSK2118436

Drug: Dacomitinib
Given PO
Other Names:
  • EGFR Inhibitor PF-00299804
  • PF-00299804
  • PF-00299804-03
  • PF-299804
  • Vizimpro

Drug: Darolutamide
Given PO
Other Names:
  • Antiandrogen ODM-201
  • BAY 1841788
  • BAY-1841788
  • BAY1841788
  • ODM 201
  • ODM-201

Drug: Dasatinib
Given PO
Other Names:
  • BMS-354825
  • Dasatinib Hydrate
  • Dasatinib Monohydrate
  • Sprycel

Drug: Doxorubicin
Given IV
Other Names:
  • Adriablastin
  • Hydroxydaunomycin
  • Hydroxyl Daunorubicin
  • Hydroxyldaunorubicin

Biological: Durvalumab
Given IV
Other Names:
  • Imfinzi
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736

Drug: Enzalutamide
Given PO
Other Names:
  • ASP9785
  • MDV3100
  • Xtandi

Drug: Erlotinib
Given PO

Drug: Everolimus
Given PO
Other Names:
  • 42-O-(2-Hydroxy)ethyl Rapamycin
  • Afinitor
  • Certican
  • RAD 001
  • RAD001
  • Votubia
  • Zortress

Drug: Fluorouracil
Given IV
Other Names:
  • 5 Fluorouracil
  • 5 Fluorouracilum
  • 5 FU
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-Fu
  • 5FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Drug: Idelalisib
Given PO
Other Names:
  • CAL-101
  • GS 1101
  • GS-1101
  • Phosphoinositide-3 Kinase Delta Inhibitor CAL-101
  • Zydelig

Drug: Imatinib
Given PO

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy

Drug: Lenvatinib
Given PO
Other Names:
  • E7080
  • ER-203492-00
  • Multi-Kinase Inhibitor E7080

Drug: Leucovorin
Given IV
Other Name: Folinic acid

Drug: Lorlatinib
Given PO
Other Names:
  • 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-
  • Lorbrena
  • PF-06463922

Drug: Losartan
Given PO

Drug: Nab-paclitaxel
Given IV
Other Names:
  • ABI 007
  • ABI-007
  • Abraxane
  • Albumin-bound Paclitaxel
  • Albumin-Stabilized Nanoparticle Paclitaxel
  • Nanoparticle Albumin-bound Paclitaxel
  • Nanoparticle Paclitaxel
  • Paclitaxel Albumin
  • paclitaxel albumin-stabilized nanoparticle formulation
  • Protein-bound Paclitaxel

Drug: Neratinib
Given PO
Other Names:
  • (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide
  • HKI 272
  • HKI-272
  • PB 272
  • PB-272

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Drug: Olaparib
Given PO
Other Names:
  • AZD 2281
  • AZD-2281
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281

Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Ai Heng
  • Aiheng
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669

Drug: Palbociclib
Given PO
Other Names:
  • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
  • Ibrance
  • PD 0332991
  • PD 332991
  • PD 991
  • PD-0332991

Drug: Panobinostat
Given PO
Other Names:
  • Faridak
  • Farydak
  • LBH589

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Biological: Pertuzumab
Given IV
Other Names:
  • 2C4
  • 2C4 Antibody
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Omnitarg
  • Perjeta
  • rhuMAb2C4
  • RO4368451

Drug: Ponatinib
Given PO
Other Names:
  • AP-24534
  • AP24534

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Drug: Regorafenib
Given PO
Other Names:
  • BAY 73-4506
  • Stivarga

Drug: Ruxolitinib
Given PO
Other Names:
  • INCB-18424
  • INCB18424
  • Jakafi
  • Oral JAK Inhibitor INCB18424

Drug: Sirolimus
Given PO
Other Names:
  • AY 22989
  • RAPA
  • Rapamune
  • Rapamycin
  • SILA 9268A
  • WY-090217

Drug: Sorafenib
Given PO
Other Names:
  • BA4 43 9006
  • BAY 43-9006
  • Bay-439006

Drug: Sunitinib
Given PO

Drug: Trametinib
Given PO
Other Names:
  • GSK1120212
  • JTP-74057
  • MEK Inhibitor GSK1120212
  • Mekinist

Biological: Trastuzumab Emtansine
Given IV
Other Names:
  • Ado Trastuzumab Emtansine
  • ADO-Trastuzumab Emtansine
  • Kadcyla
  • PRO132365
  • RO5304020
  • T-DM1
  • Trastuzumab-DM1
  • Trastuzumab-MCC-DM1
  • Trastuzumab-MCC-DM1 Antibody-Drug Conjugate
  • Trastuzumab-MCC-DM1 Immunoconjugate

Drug: Tretinoin
Given PO
Other Names:
  • 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-
  • Aberel
  • Airol
  • Aknoten
  • all trans-Retinoic acid
  • All-trans Retinoic Acid
  • All-trans Vitamin A Acid
  • all-trans-Retinoic acid
  • all-trans-Vitamin A acid
  • ATRA
  • Avita
  • beta-Retinoic Acid
  • Cordes Vas
  • Dermairol
  • Epi-Aberel
  • Eudyna
  • Renova
  • Retin-A
  • Retin-A MICRO
  • Retin-A-Micro
  • Retinoic Acid
  • Retisol-A
  • Ro 5488
  • Stieva-A
  • Stieva-A Forte
  • Trans Retinoic Acid
  • Trans Vitamin A Acid
  • trans-Retinoic Acid
  • Tretinoinum
  • Vesanoid
  • Vitamin A Acid
  • Vitamin A acid, all-trans-
  • Vitinoin

Drug: Vemurafenib
Given PO
Other Names:
  • BRAF (V600E) kinase inhibitor RO5185426
  • BRAF(V600E) Kinase Inhibitor RO5185426
  • PLX-4032
  • PLX4032
  • RG 7204
  • RG7204
  • RO 5185426
  • Zelboraf

Drug: Venetoclax
Given PO
Other Names:
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclexta
  • Venclyxto

Drug: Vismodegib
Given PO
Other Names:
  • Erivedge
  • GDC-0449
  • Hedgehog Antagonist GDC-0449

Drug: Vorinostat
Given PO
Other Names:
  • L-001079038
  • MSK-390
  • SAHA
  • Suberanilohydroxamic Acid
  • Suberoylanilide Hydroxamic Acid
  • Zolinza




Primary Outcome Measures :
  1. Feasibility of implementing an individualized treatment strategy [ Time Frame: From date of tumor board recommendation to first dose of SMMART-PRIME Therapy #1 (up to 3 months) ]
    Measured as the number of participants to receive the first dose of Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME therapy (Therapy #1) within 3 months from the date of Clinical Tumor Board providing a recommended drug combination.


Secondary Outcome Measures :
  1. Incidence of grade 3+ toxicities attributable to assigned study drug(s) [ Time Frame: 30 days post completion of each SMMART-PRIME Therapy (up to 6 months) ]
    Measured with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Criteria version 5.0.

  2. Time to treatment discontinuation [ Time Frame: Completion of SMMART-PRIME Therapy #1 (up to 6 months) ]
    Measured as time (days) from start of SMMART-PRIME Therapy #1 to discontinuation for any reason.

  3. Overall survival (OS) [ Time Frame: Death from any cause (up to 60 months after the last dose of SMMART-PRIME Therapy #1) ]
    Overall survival (OS) is defined as the time (days) from start of SMMART-PRIME Therapy #1 to death from any reason.

  4. Time to decline (TTD) [ Time Frame: Completion of SMMART-PRIME Therapy #1 (up to 6 months) ]
    Measured time (days) from start of SMMART-PRIME Therapy #1 to recorded Eastern Cooperative Oncology Group (ECOG) performance status >= 3 using cumulative incidence methods.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document
  • Participants, both men and women, must agree to use an adequate method of contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration
  • Patients must have a histologically or cytologically-confirmed metastatic solid tumor or hematological malignancy that has progressed as follows:

    • Patients with a solid tumor must have metastatic disease and have progressed on at least 1 line of established therapy that is known to provide clinical benefit, or for whom no standard curative therapy exists. Participants with newly diagnosed, unresectable, locally-advanced or metastatic pancreatic adenocarcinoma and are beginning first-line treatment with a course of chemotherapy are eligible OR
    • Participants must have a hematological malignancy that is advanced, relapsed, or refractory to at least 1 line of established therapy that is known to provide clinical for the treatment of their disease. Hematological disease included in this study are as follows:

      • Acute myelogenous leukemia (AML), or
      • Myelodysplastic syndrome (MDS), or
      • MDS/myeloproliferative neoplasms (MDS/MPN), or
      • Primary myelofibrosis (PMF)
      • Acute lymphoblastic leukemia (ALL)
      • Chronic myelogenous leukemia (CML)
      • Non-Hodgkin lymphoma (NHL) or Hodgkin's disease (HD)
      • Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
      • Multiple myeloma (MM)
  • Participants with a metastatic solid tumor or advanced hematological malignancy whom, due to medical issues cannot receive standard therapy shown to prolong survival, will be eligible, if other eligibility criteria are met

    • Patients with a metastatic solid tumor or advanced hematological malignancy that actively refuse chemotherapy that is considered standard treatment for their cancer, despite being informed by the investigator about the treatment options, are eligible for this study on a case-by-case basis (in consultation with the principal investigator [PI]). Potential participants actively refusing chemotherapy must have had progression or refractory disease prior to starting study treatment, and their refusal must be documented
  • Participants must have measurable disease:

    • Patients with solid tumors must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. At least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, per RECIST (v1.1). Note: Participants with lesions on a bone scan that are considered distinctly metastatic will also be included
    • Patients with lymphoma must have at least one non-irradiated tumor mass > 15 mm (long axis of lymph node) or > 10 mm (short axis of lymph node or extranodal lesions) on spiral CT-scan
    • Patients with CLL must have presence of radiographically measurable lymphadenopathy (defined as the presence of >= 1 nodal lesion that measures >= 2.0 cm in the longest diameter [LD] and >= 1.0 cm in the longest perpendicular diameter [LPD] as assessed by CT or magnetic resonance imaging [MRI])
    • Patients with MM must have at least one of the following: serum monoclonal component > 1 g/dL (IgG), or > 0.5 g/dL (IgA), or Bence-Jones (BJ) proteinuria > 200 mg/24 hour, or measurable plasmacytoma (not previously irradiated)
  • Participants with a hematological malignancy must have their bone marrow biopsy and aspirate reviewed at Oregon Health & Science University (OHSU)
  • Participants with a solid tumor must have lesions meeting the above criteria also and must be amenable to biopsy procedures performed per institutional standards
  • Participants must not currently be receiving any other investigational agents
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2 and a physician assessed life expectancy of >= 6 months
  • Absolute neutrophil count (ANC) >= 1,500/mcL (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Waived for those with hematological malignancy; and may be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level
  • Platelets >= 100,000/mcL (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Waived for those with hematological malignancy
  • Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Waived for those with hematological malignancy
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min/1.73 m^2 for participants with creatinine levels > 1 x institutional ULN (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Waived for those with hematological malignancy; and may be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level
  • Total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for participants with total bilirubin levels > 1.5 x ULN (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN (at time of registration and within 4 weeks prior to initiating on-protocol treatment)
  • International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (at time of registration and within 4 weeks prior to initiating on-protocol treatment)
  • Activated partial thromboplastin time (aPTT) or PTT =< 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (at time of registration and within 4 weeks prior to initiating on-protocol treatment)
  • Body mass index (BMI) > 1.6 and < 3.5 kg/m^2 (at time of registration and within 4 weeks prior to initiating on-protocol treatment)

    • Participants with a BMI of >= 3.0 will use ideal body weight indices in calculating the delivery of agents that are dosed based upon body surface area (i.e., mg agent/meter squared) or weight (i.e., mg agent/kg body weight)
  • Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or less), or major surgery must have been completed >= 4 weeks prior to start of study treatment. All adverse events due to prior therapy must have resolved to a grade 1 or better (except alopecia and lymphopenia for all disease cohorts, and hematologic toxicity for those with a hematological malignancy) by start of treatment. Palliative radiation therapy must have been completed at least 2 weeks prior to start of treatment. The radiotherapy must not be to a lesion that is included as measurable disease
  • Additional cancer-specific inclusion criteria must also be met

Key Exclusion Criteria:

  • Participants with metastases to the central nervous system that are considered uncontrolled and/or were diagnosed within the past 4 weeks of screening for this study
  • Participants cannot have an active malignancy of another cancer. Those with a history of prior malignancy will be considered on a case-by-case basis. Guiding examples for those who can be enrolled include: individuals who have been disease free for > 5 years; individuals who are considered to have a high likelihood of being cured (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer
  • Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol. There must be at least a washout period that accounts for 5 half-lives (or >= 21 days, whichever is longer) of last therapy

    • Participants with prostate cancer (PCa) will continue treatment with androgen deprivation therapy, either by prior castration or treatment with luteinizing hormone-releasing hormone (LHRH) antagonists or agonists, as is standard practice
    • Participants with breast cancer (BCa) who are HER2 positive may continue to receive anti-HER2 therapy per standard practice guidelines, while participants who are hormone receptor positive may continue to receive hormone therapy per standard practice guidelines
    • Participants with a hematological malignancy may continue to receive hydroxyurea or other hypomethylating agent for two cycles of SMMART-PRIME therapy, as described in this protocol
  • Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure
  • Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD
  • Participants with uncontrolled infection will not be enrolled until infection is treated
  • Participant is seropositive with human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)

    • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
    • Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Participants with medical conditions, inclusive of psychiatric, that in the opinion of the investigators would jeopardize the patient or the study will be excluded
  • Participants that are pregnant or breast feeding
  • ON-TREATMENT: Individuals that have medical and/or psychiatric conditions that in the opinion of investigators would jeopardize participant safety or study integrity if they were to receive on-study treatment will not proceed further treatment and will be removed from study
  • ON-TREATMENT: If performance status is ECOG > 2
  • ON-TREATMENT: History of allergic reaction to a recommended study agent or its excipients
  • Additional cancer-specific exclusion criteria requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878524


Contacts
Layout table for location contacts
Contact: Kiara Siex, MPH 503-418-3115 siex@ohsu.edu
Contact: Taylor Kelley, BS 503-494-2493 kelleyt@ohsu.edu

Locations
Layout table for location information
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Kiara Siex, MPH    503-418-3115    siex@ohsu.edu   
Contact: Taylor Kelley, BS    503-494-2493    kelleyt@ohsu.edu   
Principal Investigator: Raymond C. Bergan, MD         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Oregon Health and Science University
Investigators
Layout table for investigator information
Principal Investigator: Raymond C Bergan, MD OHSU Knight Cancer Institute
Layout table for additonal information
Responsible Party: Raymond Bergan, MD, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03878524    
Other Study ID Numbers: STUDY00015588
NCI-2020-02743 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00015588 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Carcinoma
Breast Neoplasms
Leukemia
Prostatic Neoplasms
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Adenocarcinoma
Pancreatic Neoplasms
Preleukemia
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hematologic Neoplasms
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blast Crisis
Myelodysplastic Syndromes
Primary Myelofibrosis
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Thrombocytosis