NCT00003962

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 following bone marrow transplantation in treating patients who have hematologic cancer at risk of relapse.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 1998

Shorter than P25 for phase_1 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

April 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

November 1, 1999

Last Update Submit

May 1, 2014

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell Neoplasm

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomarefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent childhood lymphoblastic lymphomarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarecurrent/refractory childhood Hodgkin lymphomachronic myelomonocytic leukemiaacute undifferentiated leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiaAIDS-related peripheral/systemic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

aldesleukinBIOLOGICAL

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Any of the following diagnoses eligible: Acute myelogenous leukemia beyond first complete remission Acute lymphoblastic leukemia Chemotherapy resistant non-Hodgkin's lymphoma Chemotherapy resistant Hodgkin's disease Multiple myeloma Primary refractory acute leukemia Secondary leukemia Chronic myelomonocytic leukemia No chronic myelogenous leukemia, aplastic anemia, or myelofibrosis HLA identical related donor required PATIENT CHARACTERISTICS: Age: 0.5 to 65 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characterisitics Hepatic: Bilirubin less than 2.5 mg/dL (unless Gilbert's syndrome present) Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within past 12 months Pulmonary: No requirement for oxygen Other: Afebrile for greater than 48 hours No active, serious infection (e.g., sepsis, mucormycosis, or uncontrolled aspergillosis) No debilitating medical or psychiatric illness that would preclude compliance Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent corticosteroids Radiotherapy: Not specified 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)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellPrecursor Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseLeukemia, Myeloid, AcuteRecurrenceLeukemia, Myelomonocytic, ChronicLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor T-Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, LymphoidLeukemia, MyeloidDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesChronic DiseaseLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-Cell

Study Officials

  • Paul V. O'Donnell, MD, PhD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 27, 2004

Study Start

April 1, 1998

Primary Completion

June 1, 2000

Study Completion

June 1, 2000

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations

US(1)