A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Non-Hodgkin's Lymphoma (NHL)

NCT00587015 | Terminated Phase 1

• 1 other identifier: CAT-8015-1003
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 3

Brief Summary

A dose-escalation study to estimate the maximum tolerated dose(MTD) of CAT-8015 that can be safely administered to a patient.

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Assess safety, estimate MTD, characterize toxicity profile, study pharmacology and observe anti-tumor activity at the MTD.

  Day 28

Secondary Outcomes (1)

• Assess immunogenicity of CAT 8015 and potential biomarkers for therapeutic or toxicity responses.

  Day 0-7; 0-14

Study Arms (1)

1

ACTIVE COMPARATOR

CAT-8015

Drug: CAT-8015

Interventions

CAT-8015 DRUG

The dose level of the initial cohort will be 5 μg/kg so cohorts will be dosed at 5, 10, 20, 30, 40, 50, 60…μg/kg until toxicity supervenes.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible to participate in the study:
• 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
• Disease characteristics: 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. 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.
• ECOG performance status of 0-2
• 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
• Life expectancy of less than 6 months, as assessed by the principal investigator
• Must be able to understand and sign informed consent
• Must be at least 18 years old
• Female and male patients must agree to use an approved method of contraception during the study

You may not qualify if:

• Subjects meeting any of the following criteria are not eligible for participation in the study:
• History of allogeneic bone marrow transplant
• Pregnant or breast-feeding females
• 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
• 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.
• 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 greater than or equal to Grade 3 unless due to anticoagulant therapy.

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Tower Hematology Oncology Medical Group

Beverly Hills, California, 90211-1850, United States

Location

NCI, National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Kalinika Hemotologii Uniwersytetu Medycznego

Lodz, 93-510, Poland

Location

MeSH Terms

Conditions

Lymphoma

Interventions

immunotoxin HA22

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Robert Leechleider, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: August 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: October 1, 2009
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

US (2); PL (1)