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

Information source: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Adult Acute Myeloid Leukemia

Intervention: Vincristine Sulfate Liposome (Drug); Laboratory Biomarker Analysis (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Comprehensive Cancer Center of Wake Forest University

Official(s) and/or principal investigator(s):
Timothy Pardee, Principal Investigator, Affiliation: Wake Forest School of Medicine


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.

Clinical Details

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Feasibility, defined as 4 of the 1st 10 patients able to complete 2 or more courses of therapy regardless of dose modifications

Secondary outcome:

Response rate (CR, CRi, PR, and MLFS)

Overall survival

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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)

Locations and Contacts

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Timothy S. Pardee, Phone: 336-716-2466, Email: tspardee@wakehealth.edu
Timothy S. Pardee, Principal Investigator
Additional Information

Starting date: May 2015
Last updated: May 22, 2015

Page last updated: August 23, 2015

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