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

NCT00462189 | Unknown Phase 1

• 1 other identifier: CAT-8015-1001
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 5

Brief 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. 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.

Conditions

Leukemia; Hairy Cell Leukemia; HCL

Keywords

CAT-8015; HA22; HCL; Relapse; Refractory; immunotherapy; immunotoxin

Outcome Measures

Primary Outcomes (4)

• 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 (2)

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

• To investigate the potential of biomarkers to predict any therapeutic or toxic response.

Interventions

Immunotoxin therapy DRUG

CAT-8015 Immunotoxin DRUG

Biological therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cambridge Antibody Technology: lead

Study Sites (5)

Stanford University School of Medicine

Stanford, California, 94305, United States

NOT YET RECRUITING

Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892, United States

RECRUITING

Klinika Hamtologii Uniwersytetu Medycznego (Medical University of Lodz)

Lodz, Poland

NOT YET RECRUITING

Royal Marsden Hospital and Institute of Cancer Research

Surrey, United Kingdom

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 16061911 BACKGROUND

• 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.

  PMID: 18596230 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Hairy Cell; Recurrence

Interventions

immunotoxin HA22; Biological Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2007
• First Posted: April 18, 2007
• Study Start: April 1, 2007
• Last Updated: April 18, 2007

Record last verified: 2007-04

Locations

US (3); PL (1); GB (1)