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B-cell Adult Acute Lymphoblastic LeukemiaPhase 1NCT00010192

Rituximab Plus Interleukin-2 in Treating Patients With Hematologic Cancer

A Phase 1 study testing rituximab, aldesleukin and laboratory biomarker analysis in people with B-cell Adult Acute Lymphoblastic Leukemia and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Monoclonal antibodies such as rituximab 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 cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rituximab, aldesleukin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Dec 2000to Jan 2003
Phase
Phase 1
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

Who may be able to join

  • Histologically or immunophenotypically proven CD20-positive B-cell lymphoproliferative disorder
  • Recurrent or progressive low-grade B-cell lymphoma with at least one prior chemotherapy regimen (may have included monoclonal antibody)
  • Relapsed intermediate-grade or high-grade B-cell lymphoma or B-lineage acute lymphoblastic leukemia and patient not a candidate for, refused, or failed prior hematopoietic stem cell transplantation
  • No chronic lymphocytic leukemia or lymphoma with more than 5,000/mm3circulating lymphoma cells
  • Measurable or evaluable disease
  • Must have failed standard curative therapy
Show all 35Show fewer
  • No CNS or leptomeningeal metastasis
  • Performance status - Karnofsky 70-100%
  • Performance status - ECOG 0-1
  • At least 4 months
  • Absolute neutrophil count at least 1,000/mm^3
  • Hemoglobin at least 10 g/dL (transfusion allowed)
  • Platelet count at least 50,000/mm^3
  • AST no greater than upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • Hepatitis B surface antigen negative
  • Creatinine no greater than ULN
  • No prior unstable coronary artery disease
  • No New York Heart Association class III or IV congestive heart failure
  • DLCO and FEV1 at least 50% of predicted
  • HIV negative
  • No other concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No infection requiring IV antibiotic therapy within the past 4 weeks
  • No other major illness that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • See Disease Characteristics
  • Prior antibody therapy allowed
  • Prior interleukin-2 or interferon alfa allowed
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • At least 4 weeks since prior systemic corticosteroids
  • At least 4 weeks since prior radiotherapy
  • At least 4 weeks since prior surgery

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I Trial Of Rituximab And Interleukin-2

Monoclonal antibodies such as rituximab 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 cancer cells. Combining rituximab with interleukin-2 may kill more cancer cells. Phase I trial to study the effectiveness of rituximab plus interleukin-2 in treating patients who have hematologic cancer.

Read the detailed description

OBJECTIVES: Determine the dose-limiting toxicity of rituximab followed by low-dose and intermediate-dose pulse interleukin-2 (IL-2) in patients with CD20-positive B-cell lymphoid malignancy.

Determine the maximum tolerated dose of intermediate-dose pulse IL-2 in this patient population.

Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study of intermediate-dose pulse aldesleukin.

Patients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin subcutaneously (SC) on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84. Cohorts of 3-6 patients receive escalating doses of intermediate-dose pulse aldesleukin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 1 year.

Being tested
rituximab, aldesleukin, laboratory biomarker analysis, pharmacological study
Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • aldesleukinBiological

    Also called IL-2, Proleukin, recombinant human interleukin-2, recombinant interleukin-2

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT00010192
Study groupRoleWhat they receive
Treatment (rituximab and aldesleukin)ExperimentalPatients receive rituximab IV on days 1, 8, 15, and 22. Patients then receive low-dose aldesleukin SC on days 29-39, 43-53, 57-67, and 71-81, and intermediate-dose aldesleukin SC on days 40-42, 54-56, 68-70, and 82-84.
Receives: Biological: rituximab; Biological: aldesleukin; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0

    Data collected will be descriptive and provide limited estimates of variability given the small sample sizes at each dose level.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startDec 2000
  3. Primary completionJan 2003

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00010192
Sponsor's protocol ID
NCI-2012-01404
Other IDs
0037, CDR0000068454, OSU-0037, NCI-130, OSU-00H0223, U01CA076576
Status last verified
Jun 2013
First submitted
2 Feb 2001
Last updated
6 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rituximab, aldesleukin and laboratory biomarker analysis in people with B-cell Adult Acute Lymphoblastic Leukemia and Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, run by National Cancer Institute (NCI) 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?

The sponsor lists 35 inclusion and 0 exclusion criteria. 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 6 Jun 2013. 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 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.

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.

What does the primary outcome measure?

MTD defined as the dose preceding that at which at least 2 of 6 patients experience DLT using NCI CTC version 2.0 (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00010192.

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 6 Jun 2013.

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