Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines

NCT00514189 | Terminated Phase 1

• 1 other identifier: 2005-0379
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy.
2. 2.To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
3. 3.To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.
4. 4.To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
5. 5.To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.

Conditions

Leukemia

Keywords

Acute Myelogenous Leukemia; Leukemia; Autologous Dendritic Cells; Vaccine; AML; mRNA

Outcome Measures

Primary Outcomes (1)

• Time to Adverse Event (AE)

  Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued

Study Arms (1)

Autologous Dendritic Cells

EXPERIMENTAL

Biological: Autologous Dendritic Cells

Interventions

Autologous Dendritic Cells BIOLOGICAL

The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).

Also known as: DCs

Autologous Dendritic Cells

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated AML except patients with inv (16), t(8;21), or t (15;17) cytogenetics or AML in first relapse.
• Patients must have \>/= 2,000 circulating blasts/ul peripheral blood or \>/= 50% blasts in bone marrow biopsy
• Performance Status 0-2

You may not qualify if:

• Medical, social or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
• Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
• History of systemic autoimmune disease
• Positive antibody to human immunodeficiency virus
• Patients with Acute promyelocytic Leukemia are not eligible for this study.
• Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17)
• Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Chitra M. Hosing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)