Clinical Trial: Monoclonal Antibodies in Treating Patients with Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining more than one monoclonal antibody may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combining two different monoclonal antibodies in treating patients who have relapsed or refractoryfollicular non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
 Drug: IDEC-114 monoclonal antibody
 Drug: rituximab
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: monoclonal antibody therapy
Phase I
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of IDEC-114 Monoclonal Antibody and Rituximab in Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is an open-label, multicenter, dose-escalation study of IDEC-114 monoclonal antibody (IDEC-114).

  • Patients receive IDEC-114 IV over 1 hour on days 3, 8, 15, and 22 and rituximab IV on days 1, 8, 15, and 22. Cohorts of 3-6 patients receive escalating doses of IDEC-114 until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  • Phase II: Patients receive IDEC-114 at the MTD and rituximab as in phase I. Patients are followed at days 29, 36, 43, and 50; months 3 and 6; every 3 months for 1.5 years; and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 39-48 patients (9-18 patients for phase I and 30 patients for phase II) will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Hemoglobin at least 8.0 g/dL
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • AST and/or ALT no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 2.0 mg/dL
  • No hydronephrosis

Cardiovascular

  • No congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No myocardial infarction within the past 6 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after study participation
  • HIV negative
  • No other primary malignancy requiring active treatment (except hormonal therapy)
  • No active uncontrolled bacterial, viral, or fungal infection
  • No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics
  • More than 3 weeks since prior biologic therapy for cancer
  • More than 6 months since prior antibody therapy for lymphoma
  • More than 6 months since prior bone marrow or stem cell transplantation
  • No prior IDEC-114 or other anti-CD80 antibody

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy for cancer (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • More than 3 weeks since prior prednisone

Radiotherapy

Surgery

  • More than 4 weeks since prior major surgery (except diagnostic surgery)

Other


Location Information


California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

Study chairs or principal investigators

Christos E. Emmanouilides, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000271926; UCLA-0207122; IDEC-114-21; UNMC-04703
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  March 6, 2003
ClinicalTrials.gov Identifier:  NCT00056043
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005