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

NCT02337478 | Terminated Phase 2 Results FDA Drug

• 4 other identifiers: IRB00030674NCI-2014-02535CCCWFU 22214P30CA012197
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  Up to 56 days

Secondary Outcomes (2)

• Response Rate (CR, CRi, PR, and MLFS)

  Up to 6 months after completion of study treatment

• Overall Survival

  Up to 6 months after completion of therapy

Study Arms (1)

Treatment (vincristine sulfate liposome)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis

Interventions

Vincristine Sulfate Liposome DRUG

Given via injection

Also known as: liposomal vincristine, Marqibo, vincristine liposomal, vincristine sulfate liposome injection

Treatment (vincristine sulfate liposome)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (vincristine sulfate liposome)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator
• Spectrum Pharmaceuticals, Inc: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Vincristine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Timothy Pardee, MD, Ph.D.
• Organization: Wake Forest University Health Sciences

tpardee@wakehealth.edu

336-716-5440

Study Officials

• Timothy Pardee

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 13, 2015
• Study Start: June 5, 2015
• Primary Completion: March 31, 2016
• Study Completion: September 4, 2017
• Last Updated: August 14, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-07

Locations

US (1)