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LeukemiaPhase 1NCT00462189

Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

A Phase 1 study testing Immunotoxin therapy, CAT-8015 Immunotoxin and Biological therapy in people with Leukemia and Hairy Cell Leukemia, run by Cambridge Antibody Technology at 5 sites in 3 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 The sponsor has not verified this record for over two years, so it may be out of date.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 an effective treatment for hairy cell leukemia(HCL) 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, Hairy Cell Leukemia, HCL
What is being tested?
Immunotoxin therapy, CAT-8015 Immunotoxin and Biological therapy
Type of treatment
Surgery or procedure
How many people
40 participants
Where
5 sitesin 3 countries
Study dates
Apr 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 hairy cell leukemia
  • Measurable disease
  • At least one of the following indications for treatment:
  • Neutropenia (ANC <1000 cells/µL)
  • Anemia (Hgb <10g/dL)
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  • Thrombocytopenia (Plt <100,000/µL)
  • An absolute lymphocyte count of >20,000 cells/µL, or
  • Symptomatic splenomegaly
  • Patient's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted <2 years, or if the patient had unacceptable toxicity to purine analog.
  • PATIENT CHARACTERISTICS:
  • Performance status • ECOG 0-2
  • Life expectancy
  • Life expectancy of greater than 6 months, as assessed by the principal investigator
  • Other
  • Patients with other cancers who meet eligibility criteria and have had less than 5 years of disease free survival will be considered on a case-by-case basis
  • Ability to understand and sign informed consent
  • Female and male patients agree to use an approved method of contraception during the study

Who cannot join

  • Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
  • History of bone marrow transplant
  • 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)
  • Baseline coagulopathy > grade 3 unless due to anticoagulant 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
  • 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: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.
  • Recent prior therapy:
  • Cytotoxic chemotherapy (except stable doses of prednisone), whole body electron beam radiation therapy, interferon, retinoids or other systemic therapy, or investigational therapy of the malignancy for 3 weeks prior to entry into the trial
  • Less than or equal to < 3 months prior monoclonal antibody therapy (i.e. rituximab)
  • Patients who have received or are receiving 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 pseudomonas-exotoxin (PE) immunotoxin administration

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States3 sites, 3 recruiting

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

    Bethesda, Maryland, 20892

    NCI Clinical Trials Referral, 888-624-1937

    Robert J Kreitman, MD

    Recruiting

  • Cancer Center of Northwestern University

    Chicago, Illinois, 60611

    Simbi Acharya, 312-695-1383

    Martin Tallman, MD

    Not yet recruiting

  • Stanford University School of Medicine

    Stanford, California, 94305

    Sylvia Quesada, RN, 650-725-4041

    Steven E Coutre, MD

    Not yet 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

United Kingdom1 site, 1 recruiting

  • Royal Marsden Hospital and Institute of Cancer Research

    Surrey

    Claire Dearden, MD, (44) 20 7352 8171

    Claire Dearden, MD

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patient With Relapsed or Refractory Hairy Cell Leukemia (HCL)

RATIONALE: The CAT-8015 immunotoxin can bind tumor cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia(HCL) that has not responded to chemotherapy, surgery or radiation therapy.

PURPOSE: Phase I dose escalation study to determine the maximum tolerated dose of CAT-8015 immunotoxin in treating patients who have hairy cell leukemia (HCL) that has not responded to treatment.

Read the detailed description

OUTLINE: Patients receive CAT-8015 IV over 30 minutes on days 1, 3, and 5 followed by rest. Treatment repeats every 4 weeks for up to a total of 10 courses in the absence of dose limiting toxicity, complete response or disease progression. Patients are followed at 1, 3, 6,12,15,18, 21, 24 months following the start of the last treatment cycle.

Cohorts of 3-6 patients each will receive escalating doses of recombinant CAT-8015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose proceeding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, between16 to 25 new patients will be added to the MTD cohort depending on how well the CAT-8015 is tolerated.

Being tested
Immunotoxin therapy, CAT-8015 Immunotoxin, Biological therapy
Keywords
CAT-8015, HA22, HCL, Relapse, Refractory, immunotherapy, immunotoxin
Medical subject headings
Leukemia, Leukemia, Hairy Cell, Recurrence

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

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

  2. Characterize the toxicity profile of CAT-8015

  3. Study the clinical pharmacology of CAT-8015

  4. Observe anti-tumor activity, if any.

Secondary outcomes (2)

  1. To assess the immunogenic potential of CAT-8015 to induce antibodies

  2. 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 posted18 Apr 2007 (estimated)
  2. Study startApr 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
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462189
Sponsor's protocol ID
CAT-8015-1001
Status last verified
Apr 2007
First submitted
16 Apr 2007
Last updated
18 Apr 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

  • Matsushita K, Margulies I, Onda M, Nagata S, Stetler-Stevenson M, Kreitman RJ. Soluble CD22 as a tumor marker for hairy cell leukemia. Blood. 2008 Sep 15;112(6):2272-7. doi: 10.1182/blood-2008-01-131987. Epub 2008 Jul 2.

    PubMed 18596230

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 Hairy Cell Leukemia, run by Cambridge Antibody Technology at 5 sites in 3 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 18 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 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Poland, United Kingdom. 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. The study lists 4 primary outcomes in all. 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 NCT00462189, which also lists 2 linked publications.

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 Apr 2007.

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