Gemtuzumab Ozogamicin and Cyclosporine in Treating Older Patients With Relapsed Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00089050

Purpose

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.

Condition	Intervention	Phase
Leukemia	Drug: cyclosporine Drug: gemtuzumab ozogamicin	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cyclosporin Cyclosporine Gemtuzumab ozogamicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy in terms of complete remission rate [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlate clinical response to laboratory studies of drug susceptibility [ Designated as safety issue: No ]

Study Start Date:

May 2004

Detailed 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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089050

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Stephen H. Petersdorf, MD

Fred Hutchinson Cancer Research Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000378021, FHCRC-1820.00
Study First Received:	August 4, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00089050
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult acute myeloid leukemia
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)

adult pure erythroid leukemia (M6b)
adult acute megakaryoblastic leukemia (M7)
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Cyclosporins

Recurrence
Antibodies, Monoclonal
Leukemia, Myelomonocytic, Acute
Leukemia
Antibodies
Leukemia, Erythroblastic, Acute
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute monoblastic leukemia
Acute myelocytic leukemia
Immunoglobulins

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009