Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

aldesleukin

daclizumab

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult Hodgkin lymphoma, recurrent adult acute myeloid leukemia, relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL negative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beth Israel Deaconess Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002681

First Posted

November 1, 1999

Last Updated

June 9, 2011

Sponsor

Roger Williams Medical Center

Collaborators

National Cancer Institute (NCI), Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00002681

Brief Title

Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma

Official Title

Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

July 1995 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

December 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Roger Williams Medical Center

Collaborators

National Cancer Institute (NCI), Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

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.

Detailed Description

OBJECTIVES: Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma. Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution. Evaluate the immunogenicity of HAT. Identify immunologic parameters that correlate with efficacy. Evaluate the preliminary efficacy of HAT in these patients. Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability). OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia). Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies. Patients are followed weekly for 2 months. PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma

Keywords

recurrent adult Hodgkin lymphoma, recurrent adult acute myeloid leukemia, relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL negative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

aldesleukin

Intervention Type

Biological

Intervention Name(s)

daclizumab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard P. Junghans, MD, PhD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Leukemia, Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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