Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 18 and over NCI, Pharmaceutical / Industry UCLA-0207122 IDEC-114-21, UNMC-04703, NCT00056043

Objectives

1. 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.
2. Determine the pharmacokinetics of this regimen in these patients.
3. Determine the efficacy of this regimen in these patients.
4. Determine the immunogenicity of this regimen in these patients.

Entry 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

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

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/mm³
• Platelet count at least 75,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Christos Emmanouilides, MD, Principal investigator		Ph: 310-206-0716; 888-798-0719 Email: cemmanou@mednet.ucla.edu

Registry Information
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
Trial Start Date		2003-01-30
Registered in ClinicalTrials.gov		NCT00056043
Date Submitted to PDQ		2003-01-29
Information Last Verified		2004-05-18
NCI Grant/Contract Number		P30-CA16042, P30-CA36727

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