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LymphomaPhase 1NCT00040950

Biological Therapy Plus Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1 study testing rituximab and agatolimod sodium in people with Lymphoma, run by Jonsson Comprehensive Cancer Center 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 such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab and agatolimod sodium
How many people
Not given
Where
1 siteUnited States
Study dates
Mar 2002to Oct 2007
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
  • CD20 positive by immunohistochemistry or flow cytometry
  • Relapsed or refractory disease
  • Bidimensionally measurable disease
  • Sole site of measurable disease within a previously irradiated field allowed provided there was disease progression at that site
  • No pre-existing ascites or pleural effusions
  • No known CNS involvement by NHL

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • Neutrophil count at least 1,000/mm3
  • Platelet count at least 50,000/mm3

Hepatic:

  • Bilirubin less than 2 mg/dL
  • Transaminase less than 2 times upper limit of normal
  • No hepatitis B or C

Renal:

  • Creatinine less than 2 mg/dL

Cardiovascular:

  • No significant cardiovascular disease
  • No New York Heart Association class III congestive heart failure
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No uncontrolled atrial or ventricular cardiac arrhythmias

Pulmonary:

  • No concurrent significant pulmonary disease

Other:

  • HIV negative
  • No acute infection requiring antibiotics
  • No fever over 38.2 degrees C within the past 3 days
  • No other malignancy within the past 5 years except basal cell or noninvasive squamous cell skin cancer or carcinoma in situ of the cervix
  • No pre-existing autoimmune disease or antibody-mediated disease, including:
  • Systemic lupus erythematosus
  • Rheumatoid arthritis
  • Multiple sclerosis
  • Sjogren's syndrome
  • Autoimmune thrombocytopenia
  • Controlled thyroid disease allowed
  • Concurrent autoantibodies without clinical autoimmune disease allowed
  • No history of allergic reactions attributed to compounds of similar composition to study drugs
  • No other medical history, including laboratory results, that would preclude study
  • No suspected or confirmed poor compliance or mental instability that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior allogeneic transplantation
  • More than 30 days since prior hematopoietic growth factors (e.g., filgrastim (G-CSF) or epoetin alfa)
  • More than 30 days since prior immunotherapy
  • More than 90 days since prior monoclonal antibodies as monotherapy for patients who were unresponsive to treatment (30 days for patients who responded to treatment and subsequently relapsed)
  • No other concurrent biological agents
  • No concurrent hematopoietic growth factors (e.g., G-CSF or epoetin alfa)

Chemotherapy:

  • More than 30 days since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • More than 30 days since prior systemic corticosteroids
  • No concurrent systemic corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • More than 30 days since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  • At least 6 months since prior coronary angioplasty
  • More than 30 days since prior immunosuppressants
  • More than 30 days since prior participation in an investigational drug study
  • No concurrent immunosuppressants
  • No concurrent anticoagulants except aspirin at doses no greater than 325 mg/day
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Multi-Center, Phase I, Open Label, Two Arm, Non-Randomized, Dose-Escalation, Study Of The Safety And Tolerability Of CPG 7909 In Patients Receiving Rituxan For Relapsed Or Refractory B-Cell Non-Hodgkin's Lymphoma

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. Biological therapies such as CpG 7909 use different ways to stimulate the immune system and stop cancer cells from growing. Combining CpG 7909 with rituximab may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of CpG 7909 plus rituximab in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of subcutaneous and IV CpG 7909 when administered with rituximab in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the disease response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of CpG 7909. Patients are sequentially assigned to 1 of 2 treatment groups.

  • Group A: Patients receive rituximab IV over 4-5 hours followed by CpG 7909 IV over 2 hours on day 1. Courses repeat weekly for 4 weeks.
  • Group B: Patients receive rituximab as above followed by CpG 7909 subcutaneously on day 1. Courses repeat weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 6-48 patients (3-24 per treatment group) will be accrued for this study.

Conditions
Lymphoma
Being tested
rituximab, agatolimod sodium
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Lymphoma, Mantle-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 posted27 Jan 2003 (estimated)
  2. Study startMar 2002
  3. Study completionOct 2007

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040950
Sponsor's protocol ID
CDR0000069423
Other IDs
UCLA-0112032, CPGI-C004-CPG7909, NCI-G02-2086
Status last verified
Jul 2003
First submitted
8 Jul 2002
Last updated
19 Dec 2013
Results posted
No

Publications

  • Leonard JP, Link BK, Emmanouilides C, Gregory SA, Weisdorf D, Andrey J, Hainsworth J, Sparano JA, Tsai DE, Horning S, Krieg AM, Weiner GJ. Phase I trial of toll-like receptor 9 agonist PF-3512676 with and following rituximab in patients with recurrent indolent and aggressive non Hodgkin's lymphoma. Clin Cancer Res. 2007 Oct 15;13(20):6168-74. doi: 10.1158/1078-0432.CCR-07-0815.

    PubMed 17947483

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rituximab and agatolimod sodium in people with Lymphoma, run by Jonsson Comprehensive 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 19 Dec 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040950, which also lists 1 linked publication.

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 19 Dec 2013.

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