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Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti-B1 Antibody.


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti-B1 Antibody.


The endpoints of the study are to determine the response rate, complete response rate,
duration of response, time to progression, time-to-treatment failure, safety, and survival
following Iodine-131 Anti-B1 Antibody therapy in patients with NHL who previously responded
(PR, CCR, or CR) with a duration of response of at least 3 months to Iodine-131 Anti-B1
Antibody therapy.


Inclusion Criteria:



- Patients must have a histologically confirmed initial diagnosis of non-Hodgkin's
B-cell lymphoma.

- Patients must have previously responded (PR, CCR, or CR) with a duration of response
of at least 3 months to Iodine-131 Anti-B1 Antibody therapy. The patient's disease
must have progressed following the response to Iodine-131 Anti-B1 Antibody therapy.

- Patients must have evidence that their tumor tissue expresses the CD20 antigen.

- Patients must have a performance status of at least 60% on the Karnofsky Scale and an
anticipated survival of at least 3 months.

- Patients must have an absolute granulocyte count (ANC)>1,500 cells/mm3 (US) or >1,500
x 109/l (UK) and a platelet count >100,000 cells/mm3 (US) or >100,000 x 109/l (UK)
within 14 days of study entry. These blood counts must be sustained without support
of hematopoietic cytokines or transfusion of blood products.

- Patients must have adequate renal function (defined as serum creatinine <1.5 x upper
limit of normal) and hepatic function (defined as total bilirubin <1.5 x upper limit
of normal and hepatic transaminases [AST and ALT] <5 x upper limit of normal) within
14 days of study entry.

- Patients must have bi-dimensionally measurable disease. At least one lesion must be
greater than or equal to 2 x 2 cm (by CT scan).

Exclusion Criteria:

- Patients with more than an average of 25% of the intratrabecular marrow space
involved by lymphoma in bone marrow biopsy specimens as assessed microscopically
within 42 days of study entry. Bilateral posterior iliac crest core biopsies are
required if the percentage of intratrabecular space involved exceeds 10% on a
unilateral biopsy. The mean of bilateral biopsies must be no more than 25%.

- Patients who have received cytotoxic chemotherapy, radiation therapy,
immunosuppressants, or cytokine treatment within 4 weeks prior to study entry (6
weeks for nitrosourea compounds) or who exhibit persistent clinical evidence of
toxicity. The use of systemic steroids must be discontinued at least 1 week prior to
study entry.

- Patients with active obstructive hydronephrosis.

- Patients with evidence of active infection requiring IV antibiotics at the time of
study entry.

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

- Patients with prior malignancy other than lymphoma, except for adequately treated
skin cancer, in situ cervical cancer, or other cancer for which the patient has been
disease-free for 5 years. Patients who have been disease-free of another cancer for
greater than 5 years must be carefully assessed at the time of study entry to rule
out recurrent disease.

- Patients with known HIV infection.

- Patients with known brain or leptomeningeal metastases.

- Patients who are pregnant or nursing (breastfeeding). Patients of childbearing
potential must undergo a serum pregnancy test within 7 days prior to study entry.
Males and females must agree to use effective contraception for 6 months following
treatment.

- Patients with previous allergic reactions to iodine. This does not include reacting
to IV iodine-containing contrast materials.

- Patients with progressive disease within 1 year of irradiation arising in a field
that has been previously irradiated with >3500 cGy.

- Patients who became HAMA positive following Iodine-131 Anti-B1 Antibody therapy or
patients who are HAMA positive at the time of enrollment.

- Patients who are concurrently receiving either approved or non-approved (through
another protocol) anti-cancer drugs or biologics.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CP-98-021

NCT ID:

NCT00022893

Start Date:

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Radioimmunotherapy
  • Monoclonal Antibody
  • Corixa
  • Bexxar
  • Anti-B1 Antibody
  • Tositumomab
  • Iodine -131 Anti-B1 Antibody
  • Iodine I 131 Tositumomab
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Rush Medical CenterChicago, Illinois  60612
University of Michigan Cancer & Geriatric CenterAnn Arbor, Michigan  48109-0936
Cornell Medical CenterNew York, New York  10021