LeukemiaPhase 1/2NCT00002681
Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
A Phase 1/2 study testing aldesleukin and daclizumab in people with Leukemia and Lymphoma, run by Roger Williams Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- aldesleukin and daclizumab
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1995to Dec 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
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.
Read the 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.
- Being tested
- aldesleukin, daclizumab
- 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
- Medical subject headings
- Leukemia, Lymphoma, Hodgkin Disease, Leukemia, Myeloid, Acute, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
daclizumabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1995
- Primary completionSep 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roger Williams Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Richard P. Junghans, MD, PhD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002681
- Sponsor's protocol ID
- CDR0000064351
- Other IDs
- BIDMC-92020534, NEDH-92020534, BIDMC-FDR001054, NCI-H95-0732
- Status last verified
- Jun 2011
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
- ClinicalTrials.gov ID
- NCT00002681
- Acronym / sponsor ID
- CDR0000064351
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Roger Williams Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Beth Israel Deaconess Medical Center
- Study start
- Jul 1995
- Primary completion
- Sep 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aldesleukin | Biological | – |
| daclizumab | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard P. Junghans, MD, PhD study chair
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aldesleukin and daclizumab in people with Leukemia and Lymphoma, run by Roger Williams Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.