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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00062894
Other study ID # CCBX001-048
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 17, 2003
Last updated September 13, 2007
Start date April 2003
Est. completion date April 2007

Study information

Verified date September 2007
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Iodine I 131 Tositumomab


Locations

Country Name City State
United States University of Michigan Medical Center Ann Arbor Michigan
United States Bay Pines VA Medical Center Bay Pines Florida
United States Rush Medical Center Chicago Illinois
United States Duke University Medical Center Durham North Carolina
United States University of Nebraska Medical Center Omaha Nebraska
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma
Secondary 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
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