Acute Myeloid Leukemia Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT02337478

Recruitment Status:

Terminated

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT02337478

Recruitment Status:

Terminated

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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