Full Text View
Tabular View
No Study Results Posted
Related Studies
Monoclonal Antibodies in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: March 6, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: Jonsson Comprehensive Cancer Center
Collaborator: 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
Biological: galiximab
Biological: rituximab
Phase I
Phase II

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

Resource links provided by NLM:


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

Additional Information:
No publications provided

Study ID Numbers: CDR0000271926, UCLA-0207122, IDEC-114-21, UNMC-04703
Study First Received: March 6, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00056043     History of Changes
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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Lymphoma, Follicular
Pharmacologic Actions
Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009