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A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older


Phase 2
60 Years
80 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older


OBJECTIVES:

Primary

- Determine the progression-free survival of older patients with relapsed or refractory
non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous
stem cell transplantation.

Secondary

- Determine the overall survival of patients treated with this regimen.

- Determine the toxicity and tolerability of this regimen in these patients.

OUTLINE:

- Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24
to determine biodistribution. Patients then receive therapeutic iodine I 131
tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until
day -4.

- Autologous stem cell transplantation: Patients undergo autologous bone marrow or
peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow
transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously
beginning on day 0 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma

- CD20+ disease

- Failed at least 1 prior standard systemic therapy

- Persistent lymphoma by physical examination, radiographic studies, bone marrow
evaluations, flow cytometry, or polymerase chain reaction

- Tumor burden less than 500 cc by computed tomography or MRI

- No splenomegaly

- Autologous hematopoietic stem cells or bone marrow harvested and cryopreserved

- No circulating lymphoma cells by morphology or flow cytometry at or near the
time of peripheral blood stem cell (PBSC) collection if unpurged PBSCs are to be
used

- 10% or less marrow involvement by flow cytometry or morphology if purged bone
marrow is to be used

- No CNS lymphoma

- No chronic lymphocytic leukemia or small lymphocytic lymphoma/well-differentiated
lymphocytic lymphoma

PATIENT CHARACTERISTICS:

Age

- 60 to 80

Performance status

- SWOG 0-1

Life expectancy

- More than 60 days

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin less than 1.5 mg/dL

Renal

- Creatinine less than 2.0 mg/dL

Cardiovascular

- No active coronary artery disease

Pulmonary

- FEV_1 at least 70% of expected

- Vital capacity at least 70% of expected

Other

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- Able to perform self-care during radiation isolation

- No major organ dysfunction

- No major infection

- No circulating anti-mouse antibody

- No other serious medical condition considered to represent contraindications to bone
marrow transplantation

- No competing causes of death that would predict life span to be less than 10
additional years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior bone marrow or stem cell transplantation

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy greater than 20 Gy to any critical normal organ (e.g., lung,
liver, spinal cord, or more than 25% of red marrow)

Surgery

- Not specified

Other

- More than 30 days since prior systemic antilymphoma therapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival measured continuously

Outcome Time Frame:

from date of transplant through date of death

Safety Issue:

No

Principal Investigator

Ajay K. Gopal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1366.00

NCT ID:

NCT00073931

Start Date:

October 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109