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A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma


OBJECTIVES:

Primary

- Determine the safety and tolerability of monoclonal antibody hA20 in patients with
refractory CD20-positive 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. Up to 10
additional patients are then entered at 1 or more dose levels to determine 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William A. Wegener, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.

Authority:

Unspecified

Study ID:

CDR0000425383

NCT ID:

NCT00112970

Start Date:

February 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • adult grade III lymphomatoid granulomatosis
  • Waldenström macroglobulinemia
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021