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Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Primary Purpose

Recurrent Adult Acute Myeloid Leukemia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vincristine Sulfate Liposome
Laboratory Biomarker Analysis
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Adult Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
  • Patients must be ineligible for, refused or having failed at least one previous salvage regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 3
  • Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation
  • Fertile men must practice effective contraceptive methods during the study period, unless documentation of infertility exists
  • Mentally competent, ability to understand and willingness to sign the informed consent form
  • No serious medical illness that would potentially increase patients' risk for toxicity
  • No active central nervous system (CNS) disease
  • No active uncontrolled bleeding/bleeding diathesis
  • No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
  • No unwillingness or inability to follow protocol requirements
  • No evidence of ongoing, uncontrolled infection
  • No requirement for immediate palliative treatment of any kind including surgery
  • No option for immediate bone marrow transplant unless patient refuses this therapy
  • Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 x upper normal limit (UNL), alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3 x UNL
  • Bilirubin =< 3 x UNL
  • Glomerular filtration rate (GFR) > 50 ml/min/1.72 m^2 or creatinine < 2 g/dL

Exclusion Criteria:

  • Serious medical illness or severe debilitating pulmonary disease that would potentially increase the patients' risk for toxicity
  • Patients with persistent grade 3 or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy
  • Patients with active central nervous system (CNS) disease
  • Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease)
  • Pregnant women, or women of child-bearing potential not using reliable means of contraception
  • Lactating females
  • Fertile men unwilling to practice contraceptive methods during the study period
  • Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
  • Unwilling or unable to follow protocol requirements
  • Evidence of ongoing, uncontrolled infection
  • Patients with known human immunodeficiency virus (HIV) infection
  • Requirement for immediate palliative treatment of any kind including surgery
  • Evidence of inadequate hepatic function (aspartate aminotransferase [AST/SGOT] =< 3 x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] =< 3 x UNL [=< 5 x ULN if liver metastases present], bilirubin =< 1.5 x UNL)
  • Evidence of inadequate renal function (creatinine > 2 g/dL)

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (vincristine sulfate liposome)

Arm Description

Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Number of Participants Able to Complete Two or More Courses of Therapy Regardless of Dose Modifications

Secondary Outcome Measures

Response Rate (CR, CRi, PR, and MLFS)
Confidence intervals will be calculated around the estimates of the response rate (CR, CRi, PR, and MLFS) of VSLI. Assuming a response rate of 0.1, with 39 participants, 95 percent confidence intervals with a 0.09 margin of error (0.01, 0.19) or a margin of error of 0.16 around a response rate of 0.5 will be created. (Complete remission (CR) bone marrow blasts <5%, absence of blasts with Auer rods; absence of extramedullary disease, absolute neutrophil count >1,000, platelet count >100,000, independence of red cell transfusions; Complete remission with incomplete recovery (CRi) all complete remission except for residual neutropenia or thrombocytopenia; partial remission (PR), decrease of bone marrow blast to 5-25%, decrease of pre-treatment bone marrow blast by at least 50%; morphologic leukemia-free state (MLFS) Bone marrow blasts <5%, absence of Aeur rods, absence of extramedullary disease, no hematologic recovery required).
Overall Survival
Kaplan-Meier estimation will be used to analyze overall survival.

Full Information

First Posted
January 9, 2015
Last Updated
July 31, 2019
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Spectrum Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02337478
Brief Title
Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official Title
An Open Label, Phase II Study of the Feasibility and Efficacy of Vincristine Sulfate Liposome Injection in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped early due to futility.
Study Start Date
June 5, 2015 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
September 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI), Spectrum Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This pilot phase II trial studies how well vincristine sulfate liposome works in treating patients with acute myeloid leukemia that has returned after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as vincristine sulfate liposome, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liposomal encapsulation prolongs bioavailability (proportion of drug that enters the circulation when introduced into the body) of vincristine sulfate, and may increase its delivery to cancer cells with fewer side effects.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the feasibility of administering vincristine sulfate liposome injection (VSLI) to relapsed or refractory acute myeloid leukemia (AML) patients having failed, refused or not a candidate for at least one chemotherapy salvage regimen. II. To observe the hematologic improvement-rate of VSLI in this patient population. SECONDARY OBJECTIVES: I. To observe the overall survival of patients treated with VSLI. II. To observe the response rate (complete remission [CR], complete remission with incomplete count recovery [CRi], partial response [PR], and morphologic leukemia free state [MLFS]) of VSLI in this patient population. OUTLINE: Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for up to 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Adult Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (vincristine sulfate liposome)
Arm Type
Experimental
Arm Description
Patients receive vincristine sulfate liposome via injection on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Vincristine Sulfate Liposome
Other Intervention Name(s)
liposomal vincristine, Marqibo, vincristine liposomal, vincristine sulfate liposome injection
Intervention Description
Given via injection
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Participants Able to Complete Two or More Courses of Therapy Regardless of Dose Modifications
Time Frame
Up to 56 days
Secondary Outcome Measure Information:
Title
Response Rate (CR, CRi, PR, and MLFS)
Description
Confidence intervals will be calculated around the estimates of the response rate (CR, CRi, PR, and MLFS) of VSLI. Assuming a response rate of 0.1, with 39 participants, 95 percent confidence intervals with a 0.09 margin of error (0.01, 0.19) or a margin of error of 0.16 around a response rate of 0.5 will be created. (Complete remission (CR) bone marrow blasts <5%, absence of blasts with Auer rods; absence of extramedullary disease, absolute neutrophil count >1,000, platelet count >100,000, independence of red cell transfusions; Complete remission with incomplete recovery (CRi) all complete remission except for residual neutropenia or thrombocytopenia; partial remission (PR), decrease of bone marrow blast to 5-25%, decrease of pre-treatment bone marrow blast by at least 50%; morphologic leukemia-free state (MLFS) Bone marrow blasts <5%, absence of Aeur rods, absence of extramedullary disease, no hematologic recovery required).
Time Frame
Up to 6 months after completion of study treatment
Title
Overall Survival
Description
Kaplan-Meier estimation will be used to analyze overall survival.
Time Frame
Up to 6 months after completion of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia Patients must be ineligible for, refused or having failed at least one previous salvage regimen Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation Fertile men must practice effective contraceptive methods during the study period, unless documentation of infertility exists Mentally competent, ability to understand and willingness to sign the informed consent form No serious medical illness that would potentially increase patients' risk for toxicity No active central nervous system (CNS) disease No active uncontrolled bleeding/bleeding diathesis No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient No unwillingness or inability to follow protocol requirements No evidence of ongoing, uncontrolled infection No requirement for immediate palliative treatment of any kind including surgery No option for immediate bone marrow transplant unless patient refuses this therapy Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =< 3 x upper normal limit (UNL), alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 3 x UNL Bilirubin =< 3 x UNL Glomerular filtration rate (GFR) > 50 ml/min/1.72 m^2 or creatinine < 2 g/dL Exclusion Criteria: Serious medical illness or severe debilitating pulmonary disease that would potentially increase the patients' risk for toxicity Patients with persistent grade 3 or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy Patients with active central nervous system (CNS) disease Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., active peptic ulcer disease) Pregnant women, or women of child-bearing potential not using reliable means of contraception Lactating females Fertile men unwilling to practice contraceptive methods during the study period Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients Unwilling or unable to follow protocol requirements Evidence of ongoing, uncontrolled infection Patients with known human immunodeficiency virus (HIV) infection Requirement for immediate palliative treatment of any kind including surgery Evidence of inadequate hepatic function (aspartate aminotransferase [AST/SGOT] =< 3 x upper normal limit [UNL], alanine aminotransferase [ALT/SGPT] =< 3 x UNL [=< 5 x ULN if liver metastases present], bilirubin =< 1.5 x UNL) Evidence of inadequate renal function (creatinine > 2 g/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Pardee
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Vincristine Sulfate Liposome in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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