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Phase I, Multicenter, Open Label, Dose Escalation Of 90Y-Zevalin Radioimmunotherapy Using A Modified Treatment Regimen For Relapsed Or Refractory CD20+ B-Cell (Follicular/Transformed) Non-Hodgkin's Lymphoma


Phase 1
19 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Phase I, Multicenter, Open Label, Dose Escalation Of 90Y-Zevalin Radioimmunotherapy Using A Modified Treatment Regimen For Relapsed Or Refractory CD20+ B-Cell (Follicular/Transformed) Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan when
administered in combination with rituximab in patients with relapsed or refractory
low-grade, follicular, or transformed CD20-positive B-cell non-Hodgkin's lymphoma
(NHL).

- Determine the toxicity of different doses of yttrium Y 90 ibritumomab tiuxetan in
patients treated with this regimen.

- Determine the frequency of reversal of bone marrow involvement with NHL in patients
treated with this regimen.

- Determine the antitumor response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan.

Patients receive rituximab IV once weekly on weeks 1-4. After 4 doses of rituximab, patients
without bone marrow involvement and cellularity greater than 50% expected receive rituximab
IV once weekly on weeks 6 and 7 and yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes
with the final dose of rituximab (day 43).

Cohorts of 5-6 patients receive escalating dose of yttrium Y 90 ibritumomab tiuxetan until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 4 of 5 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed at 6 and 12 weeks, every 2-3 months for 2 years, and then every 6
months for 2 years.

PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed low-grade, follicular, or transformed CD20-positive B-cell
non-Hodgkin's lymphoma (NHL)

- Relapsed after prior chemotherapy OR chemotherapy-resistant disease

- Failed at least 1 prior chemotherapy regimen

- CD20-positive B-cell population in lymph nodes or bone marrow for International
Working Formulation A (small lymphocytic lymphoma) and transformed NHL

- Bone marrow involvement with lymphoma less than 25% bilaterally

- No impaired bone marrow reserve defined as at least 1 of the following criteria:

- Prior myeloablative therapies with bone marrow transplantation or peripheral
blood stem cell rescue

- Platelet count less than 100,000/mm3

- Bone marrow cellularity no greater than 15%

- Marked reduction in bone marrow precursors of one or more cell lines (e.g.,
granulocytic, megakaryocytic, or erythroid)

- Failed prior stem cell collection

- No CNS lymphoma, chronic lymphocytic lymphoma, or HIV or AIDS-related lymphoma

- No diffuse small lymphocytic/marginal zone lymphoma with lymphocyte count greater
than 5,000/mm^3

- No pleural effusion NOTE: 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.

PATIENT CHARACTERISTICS:

Age:

- 19 and over

Performance status:

- WHO 0-2

Life expectancy:

- At least 6 months

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hematocrit greater than 30%

- Hemoglobin greater than 9.0 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No anti-murine antibody reactivity if prior exposure to murine antibodies or proteins

- No other primary malignancy

- No other serious nonmalignant disease or infection that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No prior radioimmunotherapy

- Prior rituximab allowed if more than 6 months to progression after an objective
response

- At least 6 weeks since prior rituximab

- At least 3 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

- Recovered from prior immunotherapy

Chemotherapy:

- See Disease Characteristics

- No prior fludarabine

- At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or
mitomycin) and recovered

- No concurrent chemotherapy

Endocrine therapy:

- At least 3 weeks since prior anticancer endocrine therapy

- No concurrent high-dose systemic corticosteroids (e.g., 50 mg or more of prednisone
as a single dose or 50 mg or less of prednisone for more than 6 doses)

Radiotherapy:

- No prior radiotherapy to more than 25% of active bone marrow (involved field or
regional)

- At least 3 weeks since prior anticancer radiotherapy and recovered

Surgery:

- At least 4 weeks since prior surgery (except diagnostic surgery) and recovered

Other:

- No other concurrent anticancer therapy

- Concurrent oral anticoagulant therapy allowed if platelet count is at least
30,000/mm3

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Andres Forero-Torres, MD, CSU

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000069282

NCT ID:

NCT00033423

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294