Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab

NCT00062894 | Completed Phase 1

• 1 other identifier: CCBX001-048
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

Iodine I 131 Tositumomab; BEXXAR; non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

Iodine I 131 Tositumomab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

Bay Pines VA Medical Center

Bay Pines, Florida, 33744, United States

Location

Rush Medical Center

Chicago, Illinois, 60612, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109-0936, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2003
• First Posted: June 19, 2003
• Study Start: April 1, 2003
• Study Completion: April 1, 2007
• Last Updated: September 17, 2007

Record last verified: 2007-09

Locations

US (6)