Trial record 1 of 4 for:    SNS01-T
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Safety and Tolerability Study of SNS01-T in Relapsed or Refractory B Cell Malignancies (Multiple Myeloma, B Cell Lymphoma, or Plasma Cell Leukemia (PCL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Senesco Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01435720
First received: September 14, 2011
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine how well SNS01-T is tolerated by relapsed or refractory multiple myeloma, B cell lymphoma or plasma cell leukemia patients when given by intravenous infusion at various doses.


Condition Intervention Phase
Multiple Myeloma
Multiple Myeloma in Relapse
Mantle Cell Lymphoma in Relapse
Diffuse Large B Cell Lymphoma in Relapse
Other B Cell Lymphoma in Relapse
Plasma Cell Leukemia
Biological: SNS01-T
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients With Relapsed or Refractory B Cell Malignancies

Resource links provided by NLM:


Further study details as provided by Senesco Technologies, Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Safety and Tolerability assessed by frequency, severity, and duration of treatment-related adverse events, changes in vitals signs, physical exams and lab values


Secondary Outcome Measures:
  • Profile of pharmacokinetics [ Time Frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose ] [ Designated as safety issue: No ]
    Cmax, area under curve, Tmax. Performed on Weeks 1, 3, 6, 10, 14, 18

  • Explore tumor response [ Time Frame: Weeks 3 and 6, and monthly during a 24-week follow-up period ] [ Designated as safety issue: No ]
    IMWG criteria, changes in M-protein, etc. for myeloma and plasma cell leukemia; Lymphoma response criteria, CT/PET scans for B cell lymphoma


Estimated Enrollment: 15
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
0.0125 mg/kg
Biological: SNS01-T
0.0125 mg/kg twice weekly x 6 weeks
Experimental: Cohort 2
0.05 mg/kg
Biological: SNS01-T
0.05 mg/kg twice weekly x 6 weeks
Experimental: Cohort 3
0.2 mg/kg
Biological: SNS01-T
0.2 mg/kg twice weekly x 6 weeks
Experimental: Cohort 4
0.375 mg/kg
Biological: SNS01-T
0.375 mg/kg twice weekly x 6 weeks

Detailed Description:

The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma, plasma cell leukemia or B cell lymphoma will be given a relatively low dose. If tolerated, a second group will receive a higher dose. If tolerated by the second group, a third and then a fourth group will receive higher doses. Treatment-related adverse events (side effects), changes in vital signs, physical examination, and laboratory values will be monitored. Patients will receive twice weekly infusions for 6 weeks and then will be followed monthly for 6 months. A secondary purpose is to explore whether SNS01-T is an effective treatment for multiple myeloma, B cell lymphoma and plasma cell leukemia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. B cell lymphoma patients must have had their diagnosis confirmed histologically. Plasma cell leukemia (PCL) patients must have peripheral clonal plasma cells >20% of peripheral WBC and >2 x 109/L. Multiple myeloma and PCL patients must have been diagnosed by having met all three of the following IMWG criteria:

    • Clonal bone marrow plasma cells >10%
    • Presence of serum and/or urinary M-protein or, if absent, kappa or lambda serum FLC must be > 10 mg/dl accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65)
    • Evidence of end-organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically, one or more of the following:

      • Hypercalcemia: serum calcium >11.5 mg/100 mL
      • Renal insufficiency: serum creatinine >2mg/dL
      • Anemia: normochromic, normocytic with a hemoglobin value >2 g/100 mL below the lower limit of normal or a hemoglobin value <10 g/100 mL
      • Bone lesions: lytic lesions, severe osteopenia, or pathologic fractures
  2. B cell lymphoma patients must have measurable disease defined as at least one lesion that can be accurately measured for response in at least two perpendicular dimensions. Multiple myeloma patients must have measurable disease defined by the following:

    • Serum M-protein ≥0.5g/dL or urine M-protein ≥ 200 mg/24 hours by protein electrophoresis
    • If neither serum nor urine M-protein meet the criteria above, then kappa or lambda serum FLC must be ≥10 mg/dL accompanied by an abnormal kappa to lambda ratio (<0.26 or >1.65) (Serum FLC should only be used for patients without measurable serum or urine M-protein spike.)
    • If neither of the above criteria are met, the presence of plasmacytomata measurable radiographically (CT, PET or MRI) or by direct measurement.
  3. Have relapsed or refractory disease after two or more prior treatment lines, each of which may have consisted of either single or multiple regimens. The investigators will ensure that patients have had the benefit of standard treatments before considering the SNS01-T clinical trial.
  4. Be at least 2 weeks beyond the last therapy and have recovered from acute toxicities of prior therapies
  5. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  6. Have life expectancy of at least 3 months
  7. Be ≥18 years of age and willing to provide written informed consent
  8. For women and men of childbearing potential, have used effective contraceptive methods for at least 4 weeks prior to dosing and agree to continue using such methods during the study, and for at least 4 weeks after completing the study
  9. For women of childbearing potential, have a negative serum pregnancy test within 24 hours before the initiation of SNS01-T therapy
  10. Have an absolute neutrophil count >1,000/mm3
  11. Have a platelet count >75,000/mm3
  12. Have total bilirubin <2.0 mg/dL
  13. Have aspartate aminotransferase and alanine aminotransferase <3 times the upper limit of normal
  14. Have serum creatinine ≤3 times the upper limit of normal
  15. Have hemoglobin ≥8.0 g/dL

Exclusion Criteria:

  1. Have presence of nonsecretory myeloma
  2. Have an indolent lymphoma such as follicular lymphoma unless the disease is rapidly progressing
  3. Requires renal dialysis
  4. Have New York Heart Association Class III-IV heart failure classification
  5. Have CNS or leptomeningeal disease
  6. Have an active infection or serious comorbid medical condition
  7. Be receiving other concurrent anticancer agents or therapies
  8. Be receiving other concurrent investigational therapies or have received investigational therapies within 4 weeks of screening or 5 half-lives, if known, whichever is shorter
  9. Be eligible to receive any other standard therapy available that is known to extend life expectancy
  10. Be currently receiving steroids unless equivalent to 20 mg of prednisone or less
  11. Be receiving or have received heparin therapeutically within two days before and after treatment with SNS01-T
  12. Be pregnant or nursing
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435720

Locations
United States, Arkansas
The University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Medical Center
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University Mary Babb Randolf Cancer Center
Morgantown, West Virginia, United States, 26506
South Africa
Unversity of Cape Town - Groote Schuur Hospital
Cape Town, South Africa
Pretoria East Hospital
Pretoria, South Africa
Sponsors and Collaborators
Senesco Technologies, Inc.
Investigators
Principal Investigator: John A Lust, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Senesco Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01435720     History of Changes
Other Study ID Numbers: SNS01-T-001
Study First Received: September 14, 2011
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Senesco Technologies, Inc.:
Multiple myeloma
B cell lymphoma
Hematologic disease
Blood protein disorder
Neoplasm, plasma cell
Mantle Cell Lymphoma
Diffuse Large B Cell Lymphoma
Plasma Cell Leukemia
B cell malignancy

Additional relevant MeSH terms:
Leukemia
Leukemia, Plasma Cell
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014