NCT00006721

S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

ACTIVE_NOT_RECRUITING

NCT ID:

NCT00006721

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase III Trial of CHOP Plus Rituximab vs CHOP Plus Iodine-131-Labeled Monoclonal Anti-B1 Antibody (Tositumomab) for Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.

Eligibility

DISEASE CHARACTERISTICS:

* Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma

* Grade I-III disease
* Cluster of differentiation antigen 20 (CD20) antigen positive
* Fewer than 5,000/mm\^3 circulating lymphoid cells on a white blood cell (WBC) differential count
* Bidimensionally measurable disease
* Bone marrow aspiration and biopsy within the past 42 days
* No clinical evidence of central nervous system (CNS) involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics
* Granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* No impaired cardiac status, including:

* Severe coronary artery disease
* Cardiomyopathy
* Congestive heart failure
* Serious arrhythmia
* Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history

Other:

* No hypersensitivity to iodine
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 6 months after study participation
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior monoclonal antibodies for cancer

Chemotherapy:

* No prior chemotherapy for lymphoma

* Prior prednisone for non-lymphoma related illnesses allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy for lymphoma

Surgery:

* See Disease Characteristics

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: rituximab
- Description: Given IV
- Arm Group Labels: Arm II (CHOP + rituximab)
- Type: DRUG
- Name: cyclophosphamide
- Description: Given IV
- Arm Group Labels: Arm I (CHOP only), Arm II (CHOP + rituximab), Arm III (CHOP + tositumomab)
- Type: DRUG
- Name: doxorubicin
- Description: Given IV
- Arm Group Labels: Arm I (CHOP only), Arm II (CHOP + rituximab), Arm III (CHOP + tositumomab)
- Type: DRUG
- Name: prednisone
- Description: Given orally
- Arm Group Labels: Arm I (CHOP only), Arm II (CHOP + rituximab), Arm III (CHOP + tositumomab)
- Type: DRUG
- Name: vincristine
- Description: Given IV
- Arm Group Labels: Arm I (CHOP only), Arm II (CHOP + rituximab), Arm III (CHOP + tositumomab)
- Type: RADIATION
- Name: tositumomab
- Description: Given IV
- Arm Group Labels: Arm III (CHOP + tositumomab)

Sponsor

SWOG Cancer Research Network