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

  • STATUS
    Recruiting
  • End date
    Feb 27, 2025
  • participants needed
    40
  • sponsor
    OHSU Knight Cancer Institute
Updated on 27 January 2021
ct scan
paclitaxel
body mass index
cancer
combinations
sirolimus
chronic myeloid leukemia
myeloid leukemia
lymphoid leukemia
hematologic malignancy
imatinib
chronic lymphocytic leukemia
lymphoma
myelofibrosis
myelodysplastic syndromes
multiple myeloma
hodgkin's disease
myeloproliferative disorder
tretinoin
dasatinib
absolute neutrophil count
ponatinib
metastatic disease
ruxolitinib
sunitinib
measurable disease
anticoagulants
direct bilirubin
fluorouracil
treatment regimen
blood disorder
leukemia
MRI
hematologic disorder
lymphocytic leukemia
glomerular filtration rate
international normalized ratio
doxorubicin
venetoclax
enasidenib
major surgery
vorinostat
metastasis
oxaliplatin
neutrophil count
cabozantinib
pancreatic adenocarcinoma
carboplatin
capecitabine
pertuzumab
erlotinib
pembrolizumab
leucovorin
bevacizumab
trastuzumab
bone scan
bicalutamide
abiraterone
enzalutamide
cabazitaxel
aptt
thromboplastin
nivolumab
ipilimumab
conjugated bilirubin
bortezomib
cancer chemotherapy
sorafenib
adenocarcinoma
solid tumor
olaparib
abemaciclib
palbociclib
lenvatinib
trametinib
idelalisib
palliative radiation therapy
mammogram
darolutamide
hematologic disorders
panobinostat
hematologic disease
myeloproliferative neoplasm
trastuzumab emtansine
dabrafenib
myeloproliferative disorders
metastatic pancreatic adenocarcinoma
plasmacytoma
mds/mpd
myelodysplastic/myeloproliferative neoplasms

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.

Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of implementing an individualized treatment strategy for advanced solid tumor and hematological malignancies based upon a comprehensive assessment of tumor and patient characteristics.

SECONDARY OBJECTIVES:

I. To describe the tolerability of implementing an individualized treatment strategy, particularly by measuring unanticipated toxicity associated with the administration of different combinations of two therapeutic agents given to an individual participant.

II. To assess the duration of treatment for participants receiving Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME Therapy #1.

III. To determine overall survival of participants with advanced solid tumors and hematological malignancies.

IV. To determine the time to decline in a participant's ability to perform activities of daily living.

EXPLORATORY OBJECTIVES:

I. To measure quality of life among enrolled participants. II. To evaluate immune-mediated tumor response among participants receiving an immunomodulatory study drug.

III. To determine the rates of response and benefit to SMMART-PRIME Therapy #1, as an individualized treatment strategy for participants with advanced solid tumor and hematological malignancies.

IV. To determine the progression-free and disease-free survival of participants with advanced solid tumors and hematological malignancies.

OUTLINE

TUMOR BIOPSY: Patients undergo collection of tissue samples. Clinical analytics are performed on the samples and analyzed by a clinical tumor board to recommend a treatment option based on those analytics. The findings from these Clinical Study Analytics are intended to provide the basis for selection of two drugs that, when administered in combination, provide an optimal and individualized treatment approach. This may or may not include a SMMART-PRIME treatment. The decision to initiate any SMMART-PRIME Therapy ultimately resides with the treating physician in conjunction with the study participant.

SMMART-PRIME TREATMENT: Patients receive a combination of 2 drugs (Drug A and Drug B, selected from interventions below). Doses will be escalated within individual patients over time. As described in detail below, escalation will occur on a monthly basis and is anticipated to occur as follows: first month -- 100% Food and Drug Administration (FDA) approved dose Drug A + 25% FDA approved dose Drug B; second month -- 100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. All dose-escalations will be reviewed and approved by an independent consultant outside of Oregon Health & Science University (OHSU).

Treatment will continue for up to the end of 6 treatment cycles (cycle length is between 21-28 days) in the absence of disease progression or unacceptable toxicity. Patients whose treatment is discontinued as a result of excess toxicity or lack of efficacy may switch to a different combination of drugs. Beyond six cycles, participants will be considered off-protocol directed treatment, and will move into long term follow-up.

After completion of study treatment, patients are followed for up to 5 years.

Details
Condition Malignant neoplasm of prostate, Pancreatic Cancer, Blast Crisis, Hematologic Malignancy, Blood disorder, Breast Cancer, Anemia, Acute myeloid leukemia, Myelosclerosis with myeloid metaplasia, chronic phase chronic myelogenous leukemia, Accelerated Phase Chronic Myelogenous Leukemia, Prostate Cancer, Early, Recurrent, Acute Myelogenous Leukemia (AML), Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma, Metastatic Pancreatic Adenocarcinoma, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage IIIA Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IVA Hodgkin Lymphoma, Ann Arbor Stage IVB Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma, Refractory Non Hodgkin Lymphoma, Refractory Multiple Myeloma, Metastatic Malignant Solid Neoplasm, Refractory Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Acute Myeloid Leukemia, Recurrent Hematologic Malignancy, Metastatic Breast Carcinoma, Metastatic Solid Tumor, Anemia; Non-Hodgkin’s Lymphoma, Islet Ce417ll Cancer, Locally Advanced Pancreatic Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Chronic Myelomonocytic Leukemia, Refractory Myelodysplastic Syndrome, Unresectable Pancreatic Adenocarcinoma, Myelofibrosis, Blood Cancer, Prostate Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Stage IIA Pancreatic Cancer AJCC v8, Stage IIB Pancreatic Cancer AJCC v8, Refractory Hematologic Malignancy, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Primary Myelofibrosis, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Chronic Lymphocytic Leukemia Refractory, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, hematopoietic and lymphoid cell neoplasm, chronic lymphocytic leukemia, relapsed, anaemia, metastatic malignant solid tumor, refractory acute myeloid leukemia (aml), hematopoietic malignancy, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Castration-Resistant Prostate Carcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Myelodysplastic/Myeloproliferative Neoplasm
Treatment Capecitabine, bicalutamide, fluorouracil, quality-of-life assessment, biopsy, carboplatin, Ipilimumab, Celecoxib, Abiraterone, Regorafenib, Everolimus, Ruxolitinib, bevacizumab, Pembrolizumab, Oxaliplatin, doxorubicin, Afatinib, Nab-paclitaxel, Leucovorin, Bortezomib, Vorinostat, Nivolumab, Enzalutamide, Sunitinib, durvalumab, Sirolimus, Imatinib, Erlotinib, tretinoin, Sorafenib, losartan, olaparib, dasatinib, Pertuzumab, Trastuzumab Emtansine, biospecimen collection, Vemurafenib, Palbociclib, Vismodegib, Cabazitaxel, Dacomitinib, Ponatinib, Neratinib, Cabozantinib, Dabrafenib, Trametinib, Cobimetinib, Abemaciclib, venetoclax, Lenvatinib, Idelalisib, Panobinostat, Copanlisib, All-trans retinoic acid, Folinic Acid, Lorlatinib, Enasidenib, Darolutamide
Clinical Study IdentifierNCT03878524
SponsorOHSU Knight Cancer Institute
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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)
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
Note: Participants with lesions on a bone scan that are considered distinctly metastatic will also be included
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) > > 16.0 and < 35.0 kg/m^2 (at time of registration and within 4 weeks prior to initiating on-protocol treatment)
Participants with a BMI of >= 30.0 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

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
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