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A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients With Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma


This is a multi-center study in which 12 patients with previously untreated or relapsed
follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose
of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of
tellurium-derived Iodine I 131 Tositumomab. Blood Pharmacokinetics, total body clearance,
tumor and organ dosimetry, and biodistribution will be assessed following administration of
the dosimetric dose.


Inclusion Criteria:



- At least 18 years of age

- Histologically confirmed diagnosis of follicular lymphoma, Grade 1, 2, or 3, or
diffuse large cell lymphoma (WHO/REAL classification).

Follicular, small cleaved; Follicular, mixed small cleaved and large cell; Follicular
large cell lymphoma Transformed diffuse large cell lymphoma following or concurrent with a
diagnosis of follicular lymphoma.

- Stage III or IV disease at the time of study entry.

- Previously untreated or recurrent lymphoma after no more than four prior qualifying
therapy regimens.

- Performance status of at least 70% on the Karnofsky Performance Scale and an
anticipated survival of at least three months.

- Bi-dimensionally measurable disease with at least one lesion measuring greater than
or equal to 2.0 cm x 2.0 cm (=4.0 cm2)by CT scan.

- Absolute B lymphocyte count (as determined by CD 19 reactivity)of 30 to 350 cell/mm3
within 21 days prior to study enrollment.

- ANC greater than or equal to 1500 cells/mm3; absolute lymphocyte count within normal
limits; and platelet count greater than or equal to 150,000/mm3 within 21 days prior
to study enrollment. Blood products and/or growth factors should not have been taken
within 4 weeks prior to blood draw.

- Adequate renal function (defined as serum creatinine < 1.5 x ULN) and hepatic
function (defined as total bilirubin < 1.5 x ULN and AST < 5 x ULN) within 21 days of
study enrollment.

- Human Anti-Murine Antibody (HAMA) negative within 21 days prior to study enrollment.

- Signed IRB approved consent form prior to any study-specific procedures being
implemented.

Exclusion Criteria:

- Greater than 25% of the intratrabecular marrow space involved by lymphoma in bone
marrow biopsy specimens as assessed microscopically within 90 days of study
enrollment. Bilateral posterior iliac crest core biopsies are required if the core
obtained on a unilateral biopsy is less than 2 cm.

- Prior chemotherapy, biologic therapy, steroids, or radiation therapy as treatment for
their NHL within 28 days prior to study enrollment.

- Prior Rituximab therapy within 120 days prior to study enrollment.

- Prior radioimmunotherapy.

- Prior splenectomy.

- Splenomegaly defined as spleen mass greater than 700 grams.

- Bulky disease as defined as any unidimensional measurement of lymphomatous mass
exceeding 7 cm.

- Prior malignancy other than lymphoma, except for adequately treated skin cancer, in
situ cervical cancer, or other cancer for which the patient has a generally accepted
risk of recurrence less than 20%.

- Central nervous system involvement by lymphoma.

- Evidence of active infection requiring IV antibiotics at the time of study
enrollment.

- Known HIV infection.

- New York Heart Association class III or IV heart disease or other serious illness
that would preclude evaluation.

- Active obstructive hydronephrosis.

- Evidence of clinically significant ascites or pleural effusion observed on screening
physical exam or baseline CAT xcan.

- Prior myeloablative therapy.

- History of failed stem cell collection.

- Pregnant or nursing patients. Patients of childbearing potential must undergo a serum
pregnancy test within 7 days of study enrollment and radiolabeled antibody is not to
be administered until a negative result is obtained. Males and females of
childbearing age, must agree to use effective contraception for six months following
the radioimmunotherapy.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

CCBX001-048

NCT ID:

NCT00062894

Start Date:

April 2003

Completion Date:

April 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Iodine I 131 Tositumomab
  • BEXXAR
  • non-Hodgkin's lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Duke University Medical CenterDurham, North Carolina  27710
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Rush Medical CenterChicago, Illinois  60612
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Bay Pines VA Medical CenterSt. Petersburg, Florida  33744