NCT00002681

Brief Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Jul 1995

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

8.2 years

First QC Date

November 1, 1999

Last Update Submit

June 9, 2011

Conditions

LeukemiaLymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent adult acute myeloid leukemiarelapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaatypical chronic myeloid leukemia, BCR-ABL negative

Interventions

aldesleukinBIOLOGICAL
daclizumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of one of the following malignancies: * Hodgkin's lymphoma * Acute myelogenous leukemia * Chronic myelogenous leukemia * Failed standard therapy or in chronic phase if on standard therapy * At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies * All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells * Measurable disease * No symptomatic CNS disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Life expectancy: * Greater than 2 months Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 3 times normal * No significant hepatic disease Renal: * Creatinine no greater than 3 times normal * No significant renal disease Cardiovascular: * No significant cardiovascular disease Pulmonary: * No significant pulmonary disease Other: * No significant endocrine, rheumatologic, or allergic disease * No HIV-I antibody * No active disease due to any of the following: * Cytomegalovirus Herpes simplex virus I/II * Hepatitis B or C Tuberculosis * Negative pregnancy test required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior murine anti-Tac monoclonal antibody Chemotherapy: * At least 4 weeks since chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since radiotherapy Surgery: * Not specified Other: * Concurrent treatment allowed for complications of primary disease

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

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaHodgkin DiseaseLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

aldesleukinDaclizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Richard P. Junghans, MD, PhD

    Beth Israel Deaconess Medical 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

January 27, 2003

Study Start

July 1, 1995

Primary Completion

September 1, 2003

Study Completion

December 1, 2003

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(1)