NCT00003868

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Donor stem cell transplantation may be able to replace immune cells that were destroyed by radiolabeled monoclonal antibody therapy, chemotherapy and radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining radiolabeled monoclonal antibody with cyclophosphamide and total-body irradiation followed by donor stem cell transplantation in treating patients who have advanced acute myeloid leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Feb 1999

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

August 24, 2010

Status Verified

August 1, 2010

Enrollment Period

6.1 years

First QC Date

November 1, 1999

Last Update Submit

August 20, 2010

Conditions

Leukemia

Keywords

recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiasecondary acute myeloid leukemiaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

cyclophosphamideDRUG
methotrexateDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
iodine I 131 monoclonal antibody BC8RADIATION
radiation therapyRADIATION

Eligibility Criteria

Age2 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia (AML) beyond first remission OR with primary refractory disease * AML that has transformed from myelodysplastic syndromes, if induction chemotherapy not recommended * Documented CD45 expression in patients with relapsed disease * Not needed for patients in remission * Circulating blast count less than 10,000/mm\^3 (may be controlled with hydroxyurea or similar agent) PATIENT CHARACTERISTICS: Age * 2 to 55 Performance status * Not specified Life expectancy * More than 60 days Hematopoietic * See Disease Characteristics Hepatic * Bilirubin less than 1.5 mg/dL (unless bilirubin is determined by the gastroenterology service to be predominantly unconjugated \[indirect\] as the result of possible hemolysis) * AST less than 1.5 times upper limit of normal (ULN) Renal * Creatinine less than 2.0 mg/dL OR less than 1.5 times ULN for age Other * Not pregnant or nursing * Fertile patients must use effective contraception * No major infection * No circulating antibodies to mouse immunoglobulins * HIV negative * Able to tolerate diagnostic or therapeutic procedures (e.g., radiation isolation) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * No radiotherapy to maximum tolerated levels to any normal organ Surgery * Not specified

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, AcuteCongenital Abnormalities

Interventions

CyclophosphamideMethotrexatePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Eneida Nemecek, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

October 7, 2003

Study Start

February 1, 1999

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

August 24, 2010

Record last verified: 2010-08

Locations

US(1)