Clinical Trial: Radioimmunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

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

Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radiation to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and ibritumomab tiuxetan in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
recurrent diffuse small lymphocytic/marginal zone lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent grade III follicular large cell lymphoma
recurrent grade I follicular small cleaved cell lymphoma
recurrent grade II follicular mixed cell lymphoma
 Procedure: biological response modifier therapy
 Procedure: radiation therapy
 Procedure: isotope therapy
 Procedure: monoclonal antibody therapy
 Procedure: antibody therapy
 Procedure: radioimmunotherapy
 Drug: ibritumomab tiuxetan
 Drug: IDEC-In2B8/rituximab
 Drug: indium In 111 ibritumomab tiuxetan
 Drug: rituximab
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Rituximab and Ibritumomab Tiuxetan Radioimmunotherapy in Patients With Relapsed or Refractory, Low-Grade, Follicular, or Transformed B-Cell Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: July 2000

OBJECTIVES: I. Determine the efficacy and safety of rituximab and ibritumomab tiuxetan radioimmunotherapy in patients with refractory or relapsed, low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive rituximab IV on days 1 and 8 immediately followed by IDEC-In2B8 IV over 10 minutes on day 1. Patients also receive ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.]

--Prior/Concurrent Therapy--

  • Biologic therapy: See Disease Characteristics; At least 6 weeks since prior rituximab; At least 3 weeks since prior immunotherapy and recovered; No prior radioimmunotherapy; At least 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
  • Endocrine therapy: Not specified
  • Radiotherapy: See Biologic therapy; At least 3 weeks since prior radiotherapy and recovered; No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional)
  • Surgery: At least 4 weeks since prior major surgery (other than diagnostic) and recovered
  • Other: At least 3 weeks since prior anticancer therapy and recovered; At least 8 weeks since prior phase II drugs and recovered; No other concurrent myelosuppressive antineoplastic agents; No other concurrent antineoplastic therapy

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: WHO 0-2
  • Life expectancy: At least 3 months
  • Hematopoietic: See Disease Characteristics; Absolute neutrophil count at least 1,500/mm3; Lymphocyte count no greater than 5,000/mm3 (for small lymphocytic lymphoma); Platelet count at least 150,000/mm3
  • Hepatic: Bilirubin no greater than 2.0 mg/dL
  • Renal: Creatinine no greater than 2.0 mg/dL
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 6 months after study; HIV negative; No serious nonmalignant disease or infection that would preclude study; No antimurine antibody reactivity

Location Information


Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States

District of Columbia
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States

Study chairs or principal investigators

Mansoor Noorali Saleh,  Study Chair,  UAB Comprehensive Cancer Center   

More Information

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

Study ID Numbers:  CDR0000067697; UAB-9930; NCI-G00-1731; GUMC-00095; IDEC-106-98
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005592
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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