Wegener's Granulomatosis |
Wegener Granulomatosis |
Clinical Trial: Monoclonal Antibody hA20 in Treating Patients With Refractory Non-Hodgkin''s Lymphoma
This study is currently recruiting patients.
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Purpose
RATIONALE: Monoclonal antibodies, such as hA20, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody hA20 in treating patients with refractory B-cell non-Hodgkin''''s lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult lymphomatoid granulomatosis adult non-Hodgkin''''s lymphoma indolent or aggressive adult non-Hodgkin''''s lymphoma | Drug: monoclonal antibody hA20 Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy | Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphatic Diseases; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Monoclonal Antibody hA20 in Patients With Refractory CD20-Positive Follicular B-Cell Non-Hodgkin''''s Lymphoma
OBJECTIVES: Primary
- Determine the safety and tolerability of monoclonal antibody hA20 in patients with refractory CD20-positive follicular B-cell non-Hodgkin''''s lymphoma.
- Determine the immunogenicity of this drug in these patients.
Secondary
- Determine the pharmacodynamics and pharmacokinetics of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20 until the optimal dose is determined. Up to 10 additional patients are treated at the optimal dose.
After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12 weeks, and then every 3 months until disease progression.
PROJECTED ACCRUAL: Approximately 19-28 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed B-cell non-Hodgkin''''s lymphoma (NHL)
- Any grade allowed
- CD20-positive disease
- Measurable disease, defined as ≥ 1 bidimensionally measurable lesion > 1.5 cm by CT scan
- Failed ≥ 1 prior standard chemotherapy regimen OR rituximab therapy for NHL
PATIENT CHARACTERISTICS: Age
- Over 18
Performance status
- ECOG 0-1 OR
- Karnofsky 80-100%
Life expectancy
- At least 6 months
Hematopoietic
- Hemoglobin > 10 g/dL*
- Absolute neutrophil count > 1,500/mm^3*
- Platelet count > 100,000/mm^3* NOTE: *Transfusion independent
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT < 2.5 times ULN
Renal
- Creatinine < 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy
- See Disease Characteristics
- At least 12 months since prior rituximab
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior investigational or conventional chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- Recovered from prior investigational or conventional radiotherapy
- At least 4 weeks since prior radiotherapy to the index lesion
Surgery
- Recovered from prior investigational or conventional surgery
Location and Contact Information
New York
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
St. Luke''''s-Roosevelt Hospital Center - Roosevelt Division, New York, New York, 10019, United States; Recruiting
William A. Wegener, MD, PhD, Study Chair, Immunomedics, Inc.
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Record last reviewed: May 2005
Last Updated: June 2, 2005
Record first received: June 2, 2005
ClinicalTrials.gov Identifier: NCT00112970
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-06-07

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