NCT00003870

Brief Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use 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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy, cyclophosphamide, and total-body irradiation followed by peripheral stem cell transplantation in treating patients who have advanced recurrent acute lymphocytic 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

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

2 active sites

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

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

April 14, 2004

Completed
Last Updated

April 2, 2010

Status Verified

March 1, 2010

Enrollment Period

2.8 years

First QC Date

November 1, 1999

Last Update Submit

March 31, 2010

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remission

Interventions

cyclophosphamideDRUG
methotrexateDRUG
allogeneic bone marrow 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: Histologically confirmed acute lymphocytic leukemia that is beyond first remission or is refractory Relapsed disease must be CD45 positive Patients in remission may be CD45 negative PATIENT CHARACTERISTICS: Age: 2 to 55 Performance status: Not specified Life expectancy: More than 60 days Hematopoietic: Circulating blast count less than 10,000/mm3 (control with hydroxyurea or similar agent allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times upper limit of normal (ULN) Must have no veno-occlusive liver disease Renal: Creatinine less than 2.0 mg/dL OR less than 1.5 times ULN for age Other: No active infection HIV negative No circulating antimouse immunoglobulin antibodies Must be able to tolerate diagnostic or therapeutic procedures (e.g., radiation isolation) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior 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 (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CyclophosphamideMethotrexateRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Dana Christine Matthews, 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

April 14, 2004

Study Start

February 1, 1999

Primary Completion

November 1, 2001

Study Completion

November 1, 2001

Last Updated

April 2, 2010

Record last verified: 2010-03

Locations

US(2)