Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
52

Summary

Conditions
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Anemia
  • Ann Arbor Stage III Hodgkin Lymphoma
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Ann Arbor Stage III Non-Hodgkin Lymphoma
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Acute Lymphoblastic Leukemia
  • Ann Arbor Stage IIIA Hodgkin Lymphoma
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Plasma Cell Myeloma
  • Refractory Chronic Lymphocytic Leukemia
  • Recurrent Hodgkin Lymphoma
  • Recurrent Acute Myeloid Leukemia
  • Refractory Malignant Solid Neoplasm
  • Ann Arbor Stage IIIB Hodgkin Lymphoma
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Small Lymphocytic Lymphoma
  • Stage IVB Prostate Cancer AJCC v8
  • Refractory Myelodysplastic Syndrome
  • Refractory Myelodysplastic/Myeloproliferative Neoplasm
  • Recurrent Myeloproliferative Neoplasm
  • Refractory Plasma Cell Myeloma
  • Metastatic Breast Carcinoma
  • Ann Arbor Stage IV Hodgkin Lymphoma
  • Ann Arbor Stage IV Non-Hodgkin Lymphoma
  • Stage IIA Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Recurrent Hematologic Malignancy
  • Stage IIB Pancreatic Cancer AJCC v8
  • Metastatic Pancreatic Adenocarcinoma
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Myelodysplastic/Myeloproliferative Neoplasm
  • Stage IV Prostate Cancer AJCC v8
  • Recurrent Myelodysplastic Syndrome
  • Stage IV Pancreatic Cancer AJCC v8
  • Refractory Hematologic Malignancy
  • Castration-Resistant Prostate Carcinoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Refractory Hodgkin Lymphoma
  • Ann Arbor Stage IVA Hodgkin Lymphoma
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Metastatic Malignant Solid Neoplasm
  • Refractory Chronic Myelomonocytic Leukemia
  • Stage II Pancreatic Cancer AJCC v8
  • Locally Advanced Pancreatic Adenocarcinoma
  • Primary Myelofibrosis
  • Refractory Primary Myelofibrosis
  • Refractory Non Hodgkin Lymphoma
  • Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis
  • Stage IVA Prostate Cancer AJCC v8
  • Ann Arbor Stage IVB Hodgkin Lymphoma
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Refractory Acute Myeloid Leukemia
  • Unresectable Pancreatic Adenocarcinoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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 impleme...

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.

Tracking Information

NCT #
NCT03878524
Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Zahi Mitri, MD, MS OHSU Knight Cancer Institute