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LeukemiaPhase 1NHLNCT00515892

Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease

A Phase 1 study testing Immunotoxin therapy, CAT-8015 Immunotoxin and Biological therapy in people with Leukemia and Non-Hodgkin's Lymphoma, run by Cambridge Antibody Technology at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Non-Hodgkin's Lymphoma, NHL
What is being tested?
Immunotoxin therapy, CAT-8015 Immunotoxin and Biological therapy
Type of treatment
Surgery or procedure
How many people
50 participants
Where
3 sitesin 2 countries
Study dates
Aug 2007to not given
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

  • DISEASE CHARACTERISTICS:
  • Confirmed diagnosis of B-cell non-Hodgkin's lymphoma
  • Measurable disease
  • Evidence of CD22-positive malignancy by the following criteria,
  • > 30% of malignant cells from a disease site CD22+ by FACS analysis or,
  • > 15% of malignant cells from a disease site must react with anti-CD22 by immunohistochemistry
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  • Patients with indolent subtypes of CD22+ B-cell non-Hodgkin's lymphoma, including, but not limited to mantle cell lymphoma, follicular lymphoma and Waldenström's macroglobulinemia, are eligible if stage III-IV.
  • Patients must have failed at least two or more courses of prior standard chemotherapy and/or biologic therapy (e.g. Rituxan). Patients with progressive mantle cell lymphoma may be eligible if they have failed one prior standard therapeutic regimen.
  • PATIENTS CHARACTERISTICS
  • Performance Status
  • ECOG 0-2
  • Life Expectancy
  • Life expectancy of less than 6 months, as assessed by the principal investigator
  • Other
  • Patients with other cancers who meet eligibility criteria and have less than 5 years of disease free survival will be considered on a case-by-case basis
  • Must be able to understand and sign informed consent
  • Female and male patients must agree to use an approved method of contraception during the study

Who cannot join

  • History of bone marrow transplant
  • Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
  • Pregnant or breast-feeding females
  • Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
  • HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
  • Hepatitis B surface antigen positive
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  • Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements
  • Hepatic function: serum transaminases (either ALT or AST) or bilirubin
  • ≥ Grade 2, unless bilirubin is due to Gilbert's disease
  • Renal function: Serum creatinine clearance ≤ 60mL/min as estimated by Cockroft-Gault formula
  • Hematologic function:
  • The ANC < 1000/cmm, or platelet count <50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy).
  • A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies
  • Baseline coagulopathy > Grade 3 unless due to anticoagulant therapy.
  • Pulmonary function:
  • Patients with < 50% of predicted forced expiratory volume (FEV1) or <50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patient with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed after bronchodilator therapy.
  • Recent prior therapy:
  • Cytotoxic chemotherapy, corticosteroids (except stable doses of prednisone), whole body electron beam radiation therapy, hormonal, biologic or other standard or any investigational therapy of the malignancy for 3 weeks prior to entry into the trial
  • Less than or equal < 3 months prior monoclonal antibody therapy (i.e. rituximab)
  • Patients who are receiving or have received radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port
  • Any history of prior pseudomonas-exotoxin immunotoxin (PE) administration.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites, 2 recruiting

  • Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892

    NCI Clinical Trials Referral Office, 888-624-1937

    Robert J Kreitman, MD

    Recruiting

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

    Marie Fuerst, RN, MS, 310-285-7269

    Peter Rosen, MD

    Recruiting

Other trials in United States

Poland1 site, 1 recruiting

  • Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)

    Lodz

    Krzysztof Jamroziak, MD, (48) 42 689-5191

    Tadeusz Robak, Professor

    Not yet recruiting

Other trials in Poland

About this study

Official title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be effective treatment for Non-Hodgkin's lymphoma (NHL) that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase 1 dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have Non-Hodgkin's lymphoma and do not respond to treatment.

Being tested
Immunotoxin therapy, CAT-8015 Immunotoxin, Biological therapy, Antibody Therapy, Monoclonal Antibody Therapy
Medical subject headings
Leukemia, Lymphoma, Non-Hodgkin

What participants receive

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

  • Immunotoxin therapyDrug

  • CAT-8015 ImmunotoxinDrug

  • Biological therapyProcedure or surgery

  • Antibody TherapyProcedure or surgery

  • Monoclonal Antibody TherapyProcedure or surgery

What is being measured

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

  1. Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.

Secondary outcomes (1)

  1. To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Timeline

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

  1. First posted14 Aug 2007 (estimated)
  2. Study startAug 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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00515892
Sponsor's protocol ID
CAT-8015-1003
Acronym
NHL
Status last verified
Aug 2007
First submitted
10 Aug 2007
Last updated
14 Aug 2007
Results posted
No
Data monitoring committee
No

Publications

  • Kreitman RJ, Squires DR, Stetler-Stevenson M, Noel P, FitzGerald DJ, Wilson WH, Pastan I. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J Clin Oncol. 2005 Sep 20;23(27):6719-29. doi: 10.1200/JCO.2005.11.437. Epub 2005 Aug 1.

    PubMed 16061911

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Immunotoxin therapy, CAT-8015 Immunotoxin and Biological therapy in people with Leukemia and Non-Hodgkin's Lymphoma, run by Cambridge Antibody Technology at 3 sites in 2 countries.

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 17 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 14 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Poland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the maximum dose that can be safely administered to a patient; Characterize the toxicity profile of CAT-8015; Study the clinical pharmacology of CAT-8015; Observe anti-tumor activity, if any.. 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 NCT00515892, 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 14 Aug 2007.

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