RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Oblimersen may increase the effectiveness of rituximab by making cancer cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with oblimersen in treating patients who have recurrent non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
adult non-Hodgkin's lymphoma	Drug: oblimersen  Drug: rituximab  Procedure: antibody therapy  Procedure: antisense therapy  Procedure: biological response modifier therapy  Procedure: monoclonal antibody therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the therapeutic efficacy and toxicity of oblimersen and rituximab in patients with recurrent B-cell non-Hodgkin's lymphoma.

OUTLINE: This is an open-label study. Patients are stratified according to type of disease (low-grade vs aggressive) and exposure/response to rituximab (naïve vs responsive vs refractory).

Patients receive oblimersen IV continuously on days 1-7, 15-21, and 29-35 and rituximab IV on days 3, 8, 15, 22, 29, and 36. Treatment repeats every 9 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 120 patients (80 rituximab-naïve/responsive [40 per disease stratum] and 40 rituximab-refractory [20 per disease stratum]) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of recurrent B-cell non-Hodgkin's lymphoma
• Transformed B-cell lymphoma allowed
• No chronic lymphocytic leukemia
• Measurable disease
• Must have received at least 1 prior treatment with an anthracycline-based or fludarabine-based regimen or an alkylating agent
• Ineligible for or refused potentially curative therapy
• No primary or metastatic CNS lymphoma

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Zubrod 0-2 OR
• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic

• See Other- Prior Concurrent Therapy
• Bilirubin no greater than 1.5 mg/dL
• SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2 times ULN
• PT and PTT no greater than 1.5 times ULN
• No history of chronic hepatitis or cirrhosis
• No prior or active hepatitis B infection (prior vaccination against hepatitis B allowed)

Renal

• Creatinine no greater than 1.8 mg/dL

Cardiovascular

• No uncontrolled congestive heart failure
• No symptomatic coronary artery disease (e.g., uncontrolled arrhythmia or recurrent chest pain despite medication)
• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• Must have adequate venous access
• No active infection
• No other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
• No active autoimmune disease
• No uncontrolled diabetes mellitus
• No seizure disorder
• No known hypersensitivity to phosphorothioate-containing oligonucleotides
• No other significant medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

• Prior rituximab, either with or without chemotherapy, allowed
• Prior response or refractory disease allowed

Chemotherapy

• See Disease Characteristics
• See Biologic therapy
• No more than 3 prior chemotherapy regimens

Endocrine therapy

• No requirement for concurrent chronic corticosteroid therapy (20 mg/day of prednisone or equivalent)

Radiotherapy

• Not specified

Surgery

• No prior organ allografts

Other

• No prior oblimersen
• More than 4 weeks since prior therapy for lymphoma
• No concurrent immunosuppressive agents
• Concurrent low-dose warfarin for maintaining catheter patency is allowed provided the INR is no greater than 1.5

Texas
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

Barbara Pro, MD,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000270426; MDA-ID-02148; NCI-5808; NCT00054639
Record last reviewed:  December 2004
Last Updated:  February 7, 2005
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054639
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08