LymphomaPhase 2NCT00059904
Rituximab and Interleukin-2 in Treating Patients With Relapsed or Refractory Intermediate- or High-Grade Non-Hodgkin's Lymphoma
A Phase 2 study testing aldesleukin and rituximab in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: 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
- Conditions the study is for
- Lymphoma
- What is being tested?
- aldesleukin and rituximab
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jun 2004
- Phase
- Phase 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:
- Diagnosis of intermediate- or high-grade non-Hodgkin's lymphoma according to the Working Formulation, including the following subtypes:
- Diffuse large cell lymphoma
- Diffuse mixed cell lymphoma
- Immunoblastic large cell lymphoma
- CD20+ disease
- Measurable progressive or refractory disease
- No primary CNS lymphoma or lymphomatous meningitis NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Lymphocyte count less than 20,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 9.5 g/dL
Hepatic
- SGOT and SGPT no greater than 1.5 times upper limit of normal
- Bilirubin normal
- No liver disease
- Hepatitis C-seropositive patients are allowed provided they have no active disease, as demonstrated by any of the following:
- Undetectable hepatitis C viral loads
- Biopsy showing no active disease
- Normal transaminases on at least 3 different occasions within the past year
Renal
- Creatinine normal
Cardiovascular
- No clinically significant cardiac dysfunction
- No myocardial infarction within the past 6 months
- No heart failure within the past 6 months
Pulmonary
- No clinically significant pulmonary dysfunction
- Patients with prior radiotherapy to the lung or autologous transplantation must have FEV greater than 50% and DLCO greater than 50% within 8 weeks before study treatment
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No significant infections within the past 2 weeks (including pneumonia or bronchitis)
- No history of autoimmune disease
- No prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or other solid tumor curatively treated with no evidence of recurrence within the past 2 years
- No symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism
- No prior type 1 hypersensitivity or anaphylactic reactions to murine products, rituximab, or radioimmunoconjugated anti-CD20 antibody infusion
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior autologous bone marrow transplantation
- No prior allogeneic bone marrow transplantation
- No prior interleukin-2
- No prior interferon (alfa, beta, or gamma)
- No concurrent basiliximab, daclizumab, or monoclonal antibody OKT3
Chemotherapy
- More than 30 days since prior chemotherapy
- No concurrent anticancer chemotherapy
Endocrine therapy
- More than 2 weeks since prior systemic steroids
- No concurrent systemic corticosteroids
Radiotherapy
- More than 30 days since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 30 days since prior major surgery
Other
- More than 30 days since other prior investigational drugs
- More than 30 days since prior immunosuppressive medications
- No concurrent immunosuppressive medications including the following:
- Cyclosporine
- Mycophenolate mofetil
- Tacrolimus
- Sirolimus
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology
RATIONALE: 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.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
- Determine the 2-year progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- aldesleukin, rituximab
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aldesleukinBiological
rituximabBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2003 (estimated)
- Study startJan 2003
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Tarun Kewalramani, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059904
- Sponsor's protocol ID
- CHIR-IL2005-A01
- Other IDs
- MSKCC-03004, CDR0000298986
- Status last verified
- Jul 2004
- First submitted
- 6 May 2003
- Last updated
- 18 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Phase II Study of Rituximab in Combination With Recombinant IL-2 for Relapsed or Refractory Non-Hodgkin's Lymphoma of Intermediate- or High-Grade Histology
- ClinicalTrials.gov ID
- NCT00059904
- Acronym / sponsor ID
- CHIR-IL2005-A01
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Study completion
- Jun 2004 (actual)
- First posted
- 7 May 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 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.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with interleukin-2 in treating patients who have relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the clinical efficacy of rituximab and interleukin-2 in patients with relapsed or refractory intermediate- or high-grade non-Hodgkin's lymphoma.
- Determine the 2-year progression-free survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Correlate response with natural killer cell numbers and rituximab, interleukin-2 (IL-2), and soluble IL-2 receptor levels in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive rituximab IV once weekly on weeks 1-4 and interleukin-2 subcutaneously 3 times weekly on weeks 2-9. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 | – |
| rituximab | 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 18 Jul 2013.
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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.
Tarun Kewalramani, MD study chair
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aldesleukin and rituximab in people with Lymphoma, run by Memorial Sloan Kettering Cancer 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 18 Jul 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 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 18 Jul 2013.