Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

A Phase II Trial Combining Gemtuzumab Ozogamicin (Mylotarg) With Cyclosporine for the Treatment of Relapsed Acute Myeloid Leukemia in Adults Over Age 60

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089050
• Other study ID #: 1820.00
• Secondary ID: FHCRC-1820.00CDR
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2004
• Last updated: November 28, 2011
• Start date: May 2004
• Est. completion date: March 2006

Study information

• Verified date: November 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Cyclosporine may increase the effectiveness of gemtuzumab ozogamicin by making cancer cells more sensitive to the drug. Combining gemtuzumab ozogamicin with cyclosporine may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemtuzumab ozogamicin together with cyclosporine works in treating older patients with relapsed acute myeloid leukemia.

Description:

OBJECTIVES:

Primary

• Determine the efficacy of gemtuzumab ozogamicin and cyclosporine, in terms of the complete remission rate, in older patients with relapsed acute myeloid leukemia.

• Determine the toxicity and pharmacokinetics of this regimen in these patients.

Secondary

• Correlate clinical response with laboratory studies of drug susceptibility in patients treated with this regimen.

OUTLINE: Patients receive cyclosporine IV continuously over 72 hours on days 1-3 and 15-17. Eight hours after initiation of each cyclosporine infusion, patients receive gemtuzumab ozogamicin IV over 2 hours on days 1 and 15. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspirate

• More than 20% blasts by morphologic criteria

• Relapsed disease = 3 months after prior complete remission

• Blasts CD33-positive by flow cytometry

• No primary hematologic disorder that preceded initial presentation with AML

• No documented secondary AML related to prior chemotherapy or toxin exposure

• No acute promyelocytic leukemia (FAB M3)

• Not a candidate for transplant therapy

• No active CNS leukemia

PATIENT CHARACTERISTICS:

Age

• 60 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC = 30,000/mm^3 (hydroxyurea allowed)

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• AST or ALT = 1.5 times ULN

Renal

• Creatinine = 1.5 mg/dL

Other

• HIV negative

• No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not planning hematopoietic stem cell transplantation immediately after study therapy

Chemotherapy

• See Disease Characteristics

• See Hematopoietic

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 1 month since prior investigational agents

• No other concurrent anticancer therapy

• No administration of any of the following for 24 hours after cyclosporine administration:

• Diltiazem

• Verapamil

• Erythromycin

• Clarithromycin

• Metoclopramide

• Phenytoin

• Rifampin

• Phenobarbital

• Aminoglycosides

• Amphotericin B

• Vancomycin

• Cimetidine

• Ranitidine

• Trimethoprim/sulfamethoxazole

• Ketoconazole

• Fluconazole

• Itraconazole

• Voriconazole

• Carbamazepine

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• cyclosporine

• gemtuzumab ozogamicin

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in terms of complete remission rate			No
Primary	Toxicity			Yes
Primary	Pharmacokinetics			No
Secondary	Correlate clinical response to laboratory studies of drug susceptibility			No