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Monoclonal Antibodies in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00056043
  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 refractory follicular non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: galiximab
Drug: rituximab
Phase I
Phase II

MedlinePlus related topics:   Cancer    Lymphoma   

ChemIDplus related topics:   Rituximab    Galiximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase I/II Trial Of IDEC-114 (Anti-CD80 Monoclonal Antibody) In Combination With Rituximab For Patients With Relapsed Or Refractory, Follicular Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 2003

Detailed Description:

OBJECTIVES:

  • Determine the safety profile and recommended phase II dose of IDEC-114 monoclonal antibody and rituximab in patients with relapsed or refractory follicular non-Hodgkin's lymphoma.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the efficacy of this regimen in these patients.
  • Determine the immunogenicity of this regimen in these patients.

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

  • Phase I: 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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed follicular non-Hodgkin's lymphoma (NHL)

    • Relapsed after or refractory to primary therapy
  • Progressive disease after at least 1 prior standard therapy, including chemotherapy, radiotherapy, biologic therapy, or bone marrow or stem cell transplantation
  • Bidimensionally measurable disease

    • At least one lesion at least 2.0 cm
  • No disease refractory to prior rituximab
  • No pleural or peritoneal effusion with positive cytology for lymphoma
  • No prior aggressive NHL or mantle cell lymphoma
  • No chronic lymphocytic leukemia
  • No CNS lymphoma

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

  • See Disease Characteristics
  • More than 3 weeks since prior radiotherapy for cancer
  • More than 6 months since prior radioimmunotherapy for lymphoma

Surgery

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

Other

  • Recovered from prior therapy
  • More than 3 weeks since other prior immunosuppressive therapy
  • Prior investigational drugs allowed
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056043

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center    
      Omaha, Nebraska, United States, 68198-7680

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Christos E. Emmanouilides, MD     Jonsson Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000271926, UCLA-0207122, IDEC-114-21, UNMC-04703
First Received:   March 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00056043
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  

Study placed in the following topic categories:
Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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