Completed

NCT Number: NCT00049179

S0117 Gemtuzumab Ozogamicin Plus Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

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. Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with cytarabine may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemtuzumab ozogamicin with cytarabine in treating patients who have relapsed acute myeloid leukemia.

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Key information

Conditions

Leukemia Bone Marrow Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

About this study

OBJECTIVES:

Determine the safety and efficacy of gemtuzumab ozogamicin and cytarabine in patients with relapsed acute myeloid leukemia.
Determine the frequency and severity of toxic effects of this regimen in CD33-positive patients.
Determine, preliminarily, the prognostic significance of drug resistance phenotype, cytogenetics, and molecular genetic characteristics of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Induction: Patients receive gemtuzumab ozogamicin IV over at least 2 hours on days 1 and 8 and cytarabine IV continuously over days 1-7.
Consolidation: Beginning between days 28 and 75, patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status receive one course of gemtuzumab ozogamicin and cisplatin as in induction chemotherapy.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study within 10-28 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Histologically confirmed acute myeloid leukemia (AML)

FAB M1-2 or M4-7
No blastic transformation of chronic myelogenous leukemia
In first relapse after prior complete response

Patients who relapsed after autologous or allogeneic bone marrow or peripheral blood stem cell transplantation are not eligible
CD33 positive
Prior myelodysplastic syndromes or secondary AML allowed
Concurrent enrollment on SWOG-9007 (cytogenetics protocol)
No clinical or documented CNS involvement with AML

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

WBC no greater than 30,000/mm^3

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST or ALT no greater than 1.5 times ULN

Renal

Not specified

Cardiovascular

No unstable cardiac arrhythmias
No unstable angina

Other

HIV negative
No other malignancy within the past 5 years except for the following:

Adequately treated basal cell or squamous cell skin cancer
Carcinoma in situ of the cervix
Adequately treated stage I or II cancer currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
No prior gemtuzumab ozogamicin for AML

Chemotherapy

Prior hydroxyurea to control high cell counts allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 4 weeks since prior investigational agents and recovered

Treatment and study plan

Cytarabine

Drug

ind and consol: 200 mg/m2/d continuous IV days 1-7

Gemtuzumab Ozogamicin

Drug

ind and consol: 6 mg/m2 IV over 2 hrs day 1, 4mg/m2 IV over 2 hrs day 8

Primary outcomes

CR

Time frame: After induction therapy is completed

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Study of Gemtuzumab Ozogamicin (Mylotarg) and Standard Dose ARA-C for Patients With Relapsed Acute Myeloid Leukemia (AML)

Important dates

Study start: 2003
Primary completion: 2005
Study completion: 2010
First posted: Jan 27, 2003
Registry last updated: Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed