S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Conditions

• Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• rituximab — BIOLOGICAL
  250 mg/m\^2, as part of Zevalin regimen
• Cyclophosphamide — DRUG
  750 mg/m\^2
• doxorubicin hydrochloride — DRUG
  50 mg/m\^2
• prednisone — DRUG
  100 mg
• vincristine sulfate — DRUG
  1.4 mg/m\^2
• radiation therapy — RADIATION
  4000-5000 cGy total
• Yttrium-90 ibritumomab tiuxetan — BIOLOGICAL
  0.4 mCi/kg
• Indium-111 ibritumomab tiuxetan — BIOLOGICAL
  5 mCi

Study Details

RATIONALE: 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. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.

Key Dates

Start date

Feb 29, 2004

Status verified

Dec 2021

Primary completion

Nov 30, 2010

Completion

Jan 8, 2015

Study Design

Enrollment

46 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: CHOP + RT + Zevalin
  Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.

Primary Outcome Measure

Progression-free Survival [ Time Frame: at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter ]

Locations (48)

Find similar trials in Anchorage, AK

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