Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Stage II, III, or IV Follicular NHL

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT00732498
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylprednisolone — DRUG
    250 mg/m2/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
  • Etoposide — DRUG
    40 mg/day IV over 1 hour days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
  • Cytarabine — DRUG
    2000 mg/m2 IV over 2 hours days 4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
  • Cisplatin — DRUG
    25 mg/m2/day IV at 1mg/min days 1,2,3,4 every 28 days for 2 cycles. If bone marrow \<25% involved and expected biodistribution after 2 cycles yttrium-90-ibritumomab tiuxetan (Zevalin) to be administered.
  • Rituximab — DRUG
    250 mg/m2 slow IV over days 1, then 7,8 or 9 prior to In Zevalin. Rituximab + Zevalin regimen is given 4-6 weeks after completion of 2 cycles of ESHAP. Treatment can be completed within 7-9 days in an outpatient setting.
  • In-Zevalin — DRUG
    5 mCi slow IV push over 10 minutes days 1. Given within 4 hours after Rituximab.
  • Y-Zevalin — DRUG
    Platelet counts from 100,000/mm3 to 149,000/mm3 will receive 0.3 mCi/kg. Platelet counts from \>/= 150,000/mm3 will receive 0.4 mCi/kg, not to exceed 32 mCi Y Zevalin. Slow IV push over 10 minutes, days 7,8 or 9 given within 4 hours after Rituximab.

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying giving combination chemotherapy followed by rituximab and yttrium Y 90 ibritumomab tiuxetan to see how well it works in treating patients with relapsed stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

Key Dates

Start date
May 15, 2006
Status verified
Aug 2019
Primary completion
Oct 15, 2018
Completion
Oct 15, 2018

Study Design

Enrollment
28 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ESHAP followed by Zevalin and Rituximab
    Etoposide, Methylprednisolone, Cytarabine, Cisplatin (ESHAP) infusion X 2 Cycles followed by Rituximab and In-Zevalin or Y-Zevalin.

Primary Outcome Measure

Progression-free Survival at 1 Year [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85724-

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The University of Arizona Cancer Center· Tucson, AZ

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