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AzTrials

LymphomaPhase 1NCT00047164

Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy

A Phase 1 study testing ipilimumab in people with Lymphoma, run by National Institutes of Health Clinical Center (CC) 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 anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
ipilimumab
How many people
89 participants
Where
1 siteUnited States
Study dates
Sep 2002to Nov 2010
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer (closed to accrual as of 3/9/2005)
  • Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154
  • Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue)
  • PSA at least 5 ng/mL
  • Progressive androgen-independent disease
  • Disease progression at least 4 weeks after flutamide withdrawal OR
  • Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal OR
  • Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005)
  • Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050
  • Progressive disease after standard treatment
  • Relapsed disease OR
  • Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05)
  • Prior therapy on protocol NCI-99-C-0023
  • Progressive disease OR
  • Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma
  • Progressive disease after standard treatment
  • No curative therapy exists
  • Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed
  • Last infusion of allogeneic cells (either hematopoietic stem cells or donor lymphocytes) must have occurred > 90 days prior to study enrollment
  • No other standard therapy available or refused such therapy
  • No symptomatic or rapidly progressive malignancy requiring therapy
  • No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • WBC at least 2,500/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 50,000/mm^3
  • Hemoglobin at least 10 g/dL
  • Hematocrit at least 30%

Hepatic

  • Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease)
  • SGOT and SGPT no greater than 3 times upper limit of normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative

Renal

  • Creatinine no greater than 2.0 mg/dL

Immunologic

  • HIV negative
  • Rheumatoid factor negative if history or evidence of arthritis
  • Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease
  • No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, lupus erythematosus, autoimmune hemolytic anemia, ulcerative and hemorrhagic colitis, endocrine disorders [e.g., thyroiditis, hyperthyroidism, hypothyroidism, autoimmune hypophysitis/hypopituitarism, or adrenal insufficiency], sarcoid granuloma, myasthenia gravis, polymyositis,or Guillain-Barre syndrome)
  • No positive antibody titers to autoimmune diseases
  • Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease
  • No active infection

Other

  • No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Recovered from prior vaccine therapy
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study
  • Patients in part II of study may have had up to 4 prior treatments with MDX-CTLA4
  • No concurrent vaccine therapy
  • No concurrent infliximab

Chemotherapy

  • At least 4 weeks since prior cytotoxic chemotherapy
  • No concurrent mercaptopurine, methotrexate, or cyclophosphamide

Endocrine therapy

  • See Disease Characteristics
  • At least 4 weeks since prior steroids
  • No concurrent systemic, inhaled, or topical steroids

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • At least 4 weeks since prior major surgery

Other

  • Prior intervening therapy for prostate cancer, non-Hodgkin's lymphoma or colon cancer allowed
  • No other concurrent investigational therapy
  • No other concurrent immunosuppressants (e.g., cyclosporine or its analog)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma

RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate cancer refractory to vaccine therapy. (part I) (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05)
  • Determine the toxicity of this drug at escalating doses in patients with follicular lymphoma. (part II)
  • Determine the toxicity of this drug at escalating doses in patients with non-Hodgkin's lymphoma or Hodgkin's lymphoma. (part III)

Secondary

  • Determine the ability of this drug to increase tumor-specific T-cell responses in these patients.
  • Determine the ability of this drug to produce clinical tumor response in these patients.
  • Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+ cells) in these patients.

OUTLINE: This is a pilot, partial dose-escalation study.

  • Part I (patients with prostate or colon cancer or follicular or mantle cell lymphomas) (prostate cancer and mantle cell lymphoma closed to accrual as of 3/10/2005; colon cancer closed to accrual as of 9/28/05): Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) IV over 90 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Part II (dose-escalation) (patients with follicular lymphomas only): Patients receive MDX-CTLA4 as in part I. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

  • Part III (dose-escalation*) (patients with non-Hodgkin's or Hodgkin's lymphoma): Patients receive MDX-CTLA4 as in part II.

NOTE: No dose-escalation for lymphoma patients who have previously been treated with an allogeneic stem cell transplantation.

Patients are followed every other month.

PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.

Conditions
Lymphoma
Being tested
ipilimumab
Keywords
recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, contiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, recurrent adult lymphoblastic lymphoma, stage I adult lymphoblastic lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, noncontiguous stage II grade 3 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, recurrent adult diffuse mixed cell lymphoma, stage I adult diffuse mixed cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Mantle-Cell

What participants receive

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

What is being measured

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

  1. Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment

Secondary outcomes (1)
  1. T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment

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 startSep 2002
  3. Primary completionSep 2010
  4. Study completionNov 2010

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
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047164
Sponsor's protocol ID
020284
Other IDs
02-C-0284, NCI-5744, CDR0000257563
Status last verified
Mar 2012
First submitted
3 Oct 2002
Last updated
26 Sep 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ipilimumab in people with Lymphoma, run by National Institutes of Health Clinical Center (CC) 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 26 Sep 2016. 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?

Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment. It is what the study was designed to measure, not a finding.

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 26 Sep 2016.

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