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LymphomaPhase 1/2NCT00003356

Rituximab Plus Interleukin-2 in Treating Patients With Lymphoma

A Phase 1/2 study testing aldesleukin and rituximab in people with Lymphoma, run by University of Rochester 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

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 cancer cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lymphoma
What is being tested?
aldesleukin and rituximab
How many people
58 participants
Where
1 siteUnited States
Study dates
Nov 1997to May 2002
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed stage II-IV low-grade, mantle cell, or follicular B-cell lymphoma Stage I disease is eligible only if radiotherapy is not considered feasible due to location of disease or previous radiation treatments No chronic lymphocytic lymphoma No small lymphocytic lymphoma with lymphocyte count greater than 5,000/mm3 Must be either first-line therapy or no more than 4 relapses after standard therapies, including chemotherapy, radiotherapy, autologous bone marrow transplantation, and/or immunotherapy Eligible if refractory to first treatment with a standard therapy Patients refractory to autologous bone marrow transplantation (ABMT) or relapsed after ABMT are eligible Patients with low-grade or follicular lymphoma must have failed at least one chemotherapy regimen Patients with mantle cell lymphoma are eligible even if no prior treatment Bidimensionally measurable disease Demonstrable monoclonal CD20-positive B-cell population in lymph nodes or bone marrow No prior diagnosis of intermediate or high-grade non-Hodgkin's lymphoma No CNS, pericardial, pleural, or peritoneal involvement by lymphoma No AIDS-related lymphoma No pleural effusion No ascites 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 to 75 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine clearance at least 65 mL/min Cardiovascular: See Disease Characteristics No pericardial effusion No New York Heart Association class III or IV heart disease No myocardial infarction within the past 6 months Other: No active, uncontrolled bacterial, viral, or fungal infection No active opportunistic infection No active inflammatory arthritis (excluding degenerative joint disease) No known hypersensitivity to interleukin-2 No history of an autoimmune disorder No history of seizure disorder No other primary malignancy in the past 5 years except squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior radioimmunotherapy At least 6 months since prior autologous bone marrow transplantation and recovered At least 4 weeks since prior colony-stimulating factors or epoetin alfa At least 3 weeks since prior immunotherapy and recovered No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered Endocrine therapy: At least 3 weeks since prior corticosteroids No corticosteroids during or for 8 weeks after study Radiotherapy: See Disease Characteristics See Biologic therapy At least 3 weeks since prior radiotherapy and recovered Surgery: Not a recipient of an allogeneic organ transplantation, unless organ is no longer functional At least 4 weeks since any prior major surgery (except diagnostic surgery) and recovered

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Rochester Cancer Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase II Study of Rituxan and IL-2 in Patients With Low Grade or Follicular B-Cell Lymphoma

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 cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining rituximab and interleukin-2 intreating patients who have low-grade mantle cell lymphoma or follicular lymphoma.

Read the detailed description

OBJECTIVES: I. Determine the response rate in patients with low-grade, mantle cell, or follicular B-cell lymphoma treated with a combination of rituximab and low-dose interleukin-2 (IL-2). II. Determine the maximum tolerated dose of IL-2 when given in conjunction with rituximab in this patient population. III. Assess whether antibody dependent cellular cytotoxicity (ADCC) is enhanced by in vivo exposure to IL-2 and whether ADCC activity correlates with clinical response in these patients. IV. Assess the incidence of antirituximab antibody formation in these patients.

OUTLINE: Patients receive interleukin-2 (IL-2) subcutaneously on days 1-5 and rituximab IV on day 3. Courses repeat weekly for up to 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed weekly for 4 weeks and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 14-29 patients with low-grade/follicular lymphoma and 14-29 patients with mantle cell lymphoma will be accrued for this study within 2-5 years.

Conditions
Lymphoma
Being tested
aldesleukin, rituximab
Keywords
stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, stage I mantle cell lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II mantle cell lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

Timeline

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

  1. First posted22 Mar 2004 (estimated)
  2. Study startNov 1997
  3. Primary completionMay 2002
  4. Study completionMay 2002

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 1/2
Primary purpose
Treatment
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003356
Sponsor's protocol ID
CDR0000066338
Other IDs
P30CA011198, URCC-U4497, NCI-G98-1442
Status last verified
Oct 2013
First submitted
1 Nov 1999
Last updated
16 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing aldesleukin and rituximab in people with Lymphoma, run by University of Rochester 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 16 Oct 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 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 16 Oct 2013.

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