Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02337478
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : June 6, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Recurrent Adult Acute Myeloid Leukemia Drug: Vincristine Sulfate Liposome Other: Laboratory Biomarker Analysis Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 5, 2015
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : September 4, 2017


Arm Intervention/treatment
Experimental: Treatment (vincristine sulfate liposome)
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.
Drug: Vincristine Sulfate Liposome
Given via injection
Other Names:
  • liposomal vincristine
  • Marqibo
  • vincristine liposomal
  • vincristine sulfate liposome injection

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Feasibility, defined as 4 of the 1st 10 patients able to complete 2 or more courses of therapy regardless of dose modifications [ Time Frame: Up to 56 days ]

Secondary Outcome Measures :
  1. Response rate (CR, CRi, PR, and MLFS) [ Time Frame: Up to 6 months after completion of study treatment ]
    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.

  2. Overall survival [ Time Frame: Time from enrollment on trial to death from any cause, assessed up to 6 months after completion of VSLI therapy ]
    Kaplan-Meier estimation will be used to analyze overall survival.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02337478


Locations
Layout table for location information
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Spectrum Pharmaceuticals, Inc
Investigators
Layout table for investigator information
Principal Investigator: Timothy Pardee Wake Forest University Health Sciences

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02337478     History of Changes
Other Study ID Numbers: IRB00030674
NCI-2014-02535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 22214 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Vincristine
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action