Clinical Trials /

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

NCT00515892

Description:

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.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Unknown status

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title:Safety Study of CAT-8015 Immunoxin in Patients With NHL With Advance Disease
  • Official Title:A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients With Relapsed or Refractory Non-Hodgkin'd Lymphoma (NHL)

Clinical Trial IDs

  • ORG STUDY ID: CAT-8015-1003
  • NCT ID: NCT00515892
  • NCT ALIAS: NCT00522483

Trial Conditions

  • Leukemia
  • Non-Hodgkin's Lymphoma
  • NHL

Trial Interventions

DrugSynonymsArms
Immunotoxin therapy
CAT-8015 Immunotoxin

Trial Purpose

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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions

Eligibility Criteria

INCLUSION CRITERIA:

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

- 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

Exclusion Criteria:

- 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

- 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.

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

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.
Time Frame:
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To assess the immunogenic potential of CAT-8015 to induce antibodies; To investigate the potential of biomarkers to predict any therapeutic or toxic response.
Time Frame:
Safety Issue:
Description:

Trial Keywords