High Dose Ara-C (HDAC) and Interleukin-2 (IL-2) for Patients With Acute Myelogenous Leukemia (AML)

NCT00136448 | Completed Phase 2

• 1 other identifier: 92-148
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will add interleukin-2 (IL-2) to a regimen of post-remission therapy consisting of high-dose ara-C. Patients with AML in first remission will receive 3 cycles of high-dose ara-C followed by continuous infusion and bolus interleukin-2 (IL-2). We, the researchers at the Dana-Farber Cancer Institute, plan to evaluate the immunologic effects of such treatment in these patients.

Conditions

Acute Myelogenous Leukemia

Keywords

AML; acute myelogenous leukemia; cytarabine; interleukin-2

Outcome Measures

Primary Outcomes (1)

• The primary purpose of this study is to evaluate the ability of IL-2 to generate cytotoxic and inhibitory activity against cryopreserved autologous leukemic myeloblasts obtained at the time of diagnosis.

Secondary Outcomes (3)

• To evaluate the safety of continuous infusion IL-2 with intermittent IL-2 boluses in patients with AML who have received 3 cycles of post-remission intensification therapy with high-dose ara-C

• To assess additional immunologic effects of IL-2

• To obtain preliminary data regarding the rate of disease relapse

Interventions

cytosine arabinoside (ara-C) DRUG

daunomycin DRUG

interleukin-2 DRUG

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 AML based on French-American-British (FAB) criteria.
• Patients must have a total bilirubin of \< 2.0 mg/dL, SGOT \< 90 IU/mL, alkaline phosphatase \< 250 U/mL and a serum creatinine \< 2.0 mg/dL.
• Age 18 years or greater.

You may not qualify if:

• History of an antecedent hematologic malignancy such as myelodysplastic syndromes (MDS).
• Uncontrolled infection.
• History of a previous or concomitant malignancy other than non-melanoma skin cancer.
• Evidence of central nervous system (CNS) leukemia.
• Current use of corticosteroids.
• Prior treatment for AML, other than hydroxyurea.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Daunorubicin; Interleukin-2

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Richard M. Stone, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2005
• First Posted: August 29, 2005
• Study Start: February 1, 1993
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

US (1)