Safety Study of CAT-8015 Immunotoxin in Patients With CLL, PLL or SLL With Advance Disease

NCT00457860 | Unknown Phase 1

• 1 other identifier: CAT-8015-1002
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 4

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 chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), or small lymphocytic lymphoma (SLL 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 chronic lymphocytic leukemia, prolymphocytic leukemia or small lymphocytic lymphoma that has not responded to treatment

Conditions

Leukemia

Keywords

CLL; PLL; SLL; Relapse; Refractory; immunotoxin; HA22; CAT-8015; immunotherapy

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 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 B-cell leukemia (CLL, PLL or SLL)
• Measurable disease
• Patients with chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL) are eligible if they have failed 2 or more prior courses of standard chemotherapy and/or biologic therapy (e.g. Rituxan) and if treatment for progressive disease is medically indicated. Patients with prolymphocytic leukemia (PLL) will be eligible if they have failed at least one prior standard chemotherapeutic regimen. Medical indications for treatment include progressive disease-related symptoms, progressive cytopenias due to marrow involvement, progressive or painful splenomegaly or adenopathy, rapidly increasing lymphocytosis, autoimmune hemolytic anemia or thrombocytopenia and increased frequency of infections.
• 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

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 direct bilirubin:
• ≥ Grade 2, unless bilirun 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 (4)

Tower Hematology Oncology Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Warren Grant Megnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892, United States

RECRUITING

Klinika Hemtologii Uniwersytetu Medycznego (Medical University of Lodz)

Lodz, Poland

NOT YET RECRUITING

Related Publications (1)

• 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

MeSH Terms

Conditions

Leukemia; Recurrence

Interventions

immunotoxin HA22; Biological Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic 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 5, 2007
• First Posted: April 9, 2007
• Study Start: March 1, 2007
• Last Updated: April 17, 2007

Record last verified: 2007-04

Locations

PL (1); US (3)