Oblimersen, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen when given together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in treating patients with stage II, stage III, or stage IV large B-cell lymphoma

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Oblimersen; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed* CD20+ diffuse large B-cell lymphoma, including any of the following stages:

• Extensive stage II (not radio-encompassable within a single involved field or not a candidate for brief chemotherapy and radiotherapy)

• Bulky stage II (any single mass greater than 10 cm)

• Stage III

• Stage IV NOTE: *Confirmed by tissue biopsy

• Previously untreated disease

• Measurable disease

• At least 2 cm by imaging studies

• Circulating lymphoma cells no greater than 5,000/mm^3

• No history of other lymphoproliferative disorder

• No history of indolent lymphoma

• No T-cell lymphoma

• No CNS involvement

• No post-transplantation lymphoproliferative disorder

PATIENT CHARACTERISTICS:

Age

• 19 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3 (unless due to bone marrow involvement with lymphoma)

• Platelet count at least 100,000/mm^3 (unless due to splenomegaly or bone marrow involvement with lymphoma)

Hepatic

• Bilirubin no greater than 3 mg/dL (unless due to lymphoma)

• No known hepatitis B virus

Renal

• Creatinine no greater than 2 mg/dL (unless due to lymphoma)

Cardiovascular

• No cardiac contraindication to doxorubicin therapy (e.g., abnormal contractility on echocardiography)

• History of cardiac disease allowed provided ejection fraction is normal

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Adequate venous access

• HIV negative

• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer, localized basal cell or squamous cell skin cancer, or curatively treated carcinoma in situ of the cervix

• No neurological contraindication to vincristine (e.g., peripheral neuropathy)

• No active systemic infection

• No medical condition that would compromise study treatment, add toxicity, or impair assessment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

• Prior radiotherapy for localized basal cell or squamous cell skin cancer used with curative intent allowed

Surgery

• Not specified