Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• filgrastim — BIOLOGICAL
  Cycle 1: 300 ug (BW \< = 70 kg) or 480ug (BW \>70 kg) sub Q injection Day 6 until ANC \> 5000/uL after nadir counts Subsequent cycle dosages based on previous cycle toxicity or Day 1 Tx toxicity
• rituximab — BIOLOGICAL
  375 mg/sq m IV infusion Day 1 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 of tx toxicities
• cyclophosphamide — DRUG
  750 mg/sq m IV infusion on Day 5 Cycle 1 Subsequent cycle dosage based on previous cycle or day 1 treatment toxicities
• doxorubicin hydrochloride — DRUG
  10 mg/sq m/day continuous IV infusion on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and Day 1 treatment toxicities
• etoposide — DRUG
  50 mg/sq m/day continuous IV infusion Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities
• prednisone — DRUG
  60 mg/sq m PO bid days 1-5 of ea cycle
• vincristine sulfate — DRUG
  0.4 mg/sq m/day continuous IV infusion uncapped on Days 1-4 Cycle 1 Subsequent cycle dosages based on previous cycle and day 1 of treatment toxicities

Study Details

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy in treating patients who have previously untreated non-Hodgkin's lymphoma.

Key Dates

Start date

Feb 28, 2002

Status verified

Jul 2016

Primary completion

Dec 31, 2004

Completion

Apr 30, 2009

Study Design

Enrollment

78 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: EPOCH-Rituximab
  Addition of monoclonal antibody therapy to chemotherapy for treatment of pts with aggressive CD20+ NHL

Primary Outcome Measure

Response [ Time Frame: 5 months ]

Locations (80)

Find similar trials in Anniston, AL

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