NCT00089050

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

November 30, 2011

Status Verified

November 1, 2011

First QC Date

August 4, 2004

Last Update Submit

November 28, 2011

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiaadult 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 leukemiaadult acute eosinophilic leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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)

Outcome Measures

Primary Outcomes (3)

  • Efficacy in terms of complete remission rate

  • Toxicity

  • Pharmacokinetics

Secondary Outcomes (1)

  • Correlate clinical response to laboratory studies of drug susceptibility

Interventions

cyclosporineDRUG
gemtuzumab ozogamicinDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteCongenital Abnormalities

Interventions

CyclosporineGemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsCalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Stephen H. Petersdorf, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

May 1, 2004

Study Completion

March 1, 2006

Last Updated

November 30, 2011

Record last verified: 2011-11

Locations

US(1)