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

Alternate Title

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed Over 18 Other, Pharmaceutical / Industry VMRC-6249 NEORX-9802, NCI-V98-1471

Objectives

I.  Evaluate the safety, pharmacokinetics, and biologic effect of pretargeted 
radioimmunotherapy (PRIT) in patients with relapsed non-Hodgkin's lymphoma.

II.  Define the optimal dosing and timing schema for the PRIT components such 
that tumor to whole body ratio is greater than 20:1.

III.  Assess the need for cold blocker and, if needed, determine the 
appropriate dose and timing of cold blocker administration.

IV.  Assess the immunogenicity of the PRIT components after intravenous 
administration to patients with non-Hodgkin's lymphoma.

Entry Criteria

Disease Characteristics:

Confirmed CD20+ stage II, IIE, III or IV non-Hodgkin's lymphoma that is
persistent after standard therapy or for which no effective standard therapy
exists

Evaluable disease required

No clinical evidence of CNS involvement

Prior/Concurrent Therapy:

Biologic therapy:
 At least 4 weeks since prior antibody therapy
 Prior transplant allowed

Chemotherapy:
 At least 4 weeks since prior chemotherapy

Endocrine therapy:
 Not specified

Radiotherapy:
 At least 4 weeks since prior radiotherapy

Surgery:
 Not specified

Patient Characteristics:

Age:
 Over 18

Performance status:
 Karnofsky 60-100%

Life expectancy:
 At least 3 months

Hematopoietic:
 Platelet count at least 100,000/mm3
 Absolute neutrophil count at least 2000/mm3

Hepatic:
 Bilirubin no greater than 2.0 mg/dL

Renal:
 Creatinine no greater than 2.0 mg/dL
 No glomerulonephritis that would significantly hamper study treatment

Cardiovascular:
 No severe hypertension, collagen vascular disease, or vasculitis that would
  significantly hamper study treatment

Pulmonary:
 No asthma that would significantly hamper study treatment

Other:
 Not pregnant or nursing
 Fertile patients must use effective contraception
 No elevated antibody titer against C2B8
 No other prior hematologic malignancy
 No other serious illness that would significantly hamper study treatment
 No uncontrolled active infection

Expected Enrollment

Approximately 14 patients will be accrued for this study.

Outline

This is a dose escalation study.

Patients receive rituximab-streptavidin (C2B8-SA) conjugate IV that may be 
labeled with Rhenium-186.  Prior to C2B8-SA conjugate, patients may receive 
rituximab IV.  Patients are then given a clearing agent to remove unbound 
antibodies.  All patients receive biotin conjugated to DOTA (DOTA-biotin) 
labelled with Indium-111 and with or without Yttrium-90.  Patients who receive 
C2B8-SA conjugate labelled with Rhenium-186 will undergo gamma camera imaging 
studies prior to administration of the clearing agent.

Patients are followed weekly for the first 6 weeks, then at weeks 8 and 12, 
and every 6 months for 2 years.

Trial Contact Information

Trial Lead Organizations

Virginia Mason Medical Center

Paul Weiden, MD, Protocol chair(Contact information may not be current)		Ph: 206-223-6600