Overview

This trial is active, not recruiting.

Conditions 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
Treatments sns01-t
Phase phase 1/phase 2
Sponsor Senesco Technologies, Inc.
Start date September 2011
End date October 2014
Trial size 15 participants
Trial identifier NCT01435720, SNS01-T-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
0.0125 mg/kg
sns01-t
0.0125 mg/kg twice weekly x 6 weeks
(Experimental)
0.05 mg/kg
sns01-t
0.05 mg/kg twice weekly x 6 weeks
(Experimental)
0.2 mg/kg
sns01-t
0.2 mg/kg twice weekly x 6 weeks
(Experimental)
0.375 mg/kg
sns01-t
0.375 mg/kg twice weekly x 6 weeks

Primary Outcomes

Measure
Safety and tolerability
time frame: Week 6

Secondary Outcomes

Measure
Profile of pharmacokinetics
time frame: 0.5 hours pre-dose and 0.5, 2, 6 and 24 hours post-dose
Explore tumor response
time frame: Weeks 3 and 6, and monthly during a 24-week follow-up period

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator John A Lust, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Senesco Technologies, Inc..