Status:
COMPLETED
Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...
Detailed Description
OBJECTIVES: Primary * Determine the response rate (complete response \[CR\], unconfirmed CR, and partial response) in patients with previously untreated stage III or IV follicular B-cell non-Hodgkin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Pathologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
- Stage III or IV disease
- Grade 1 or 2 disease
- Previously untreated disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
- Clearly defined bidimensional diameter ≥ 2 x 2 cm on physical examination OR \> 2.0 cm in 1 of the dimensions by CT scan, MRI, or plain radiograph imaging
- Splenic enlargement may be used as a measurable parameter if the spleen is palpable ≥ 3 cm below the left costal margin
- Circulating tumor cells \< 5,000/mm³
- Must have paraffin-embedded tissue blocks/slides available
- No CNS lymphoma
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 1 year
- WBC ≥ 3,400/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10.0 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- AST ≤ 3 times ULN
- Creatinine ≤ 1.5 times ULN
- Albumin ≥ 3 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after completion of study therapy
- No HIV infection
- No other active malignancies
- No active uncontrolled infection
- No known hypersensitivity to denileukin diftitox or any of its components, including diphtheria toxin, aldesleukin, or excipients
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy, immunotherapy, vaccines, or radiotherapy for NHL
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00460109
Start Date
April 1 2008
End Date
March 1 2011
Last Update
April 18 2017
Active Locations (165)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933