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PHASE II TRIAL OF YTTRIUM-90-IBRITUMOMAB TIUXETAN (ZEVALIN) RADIOIMMUNOTHERAPY AFTER CYTOREDUCTION WITH ESHAP CHEMOTHERAPY IN PATIENTS WITH RELAPSED FOLLICULAR NON-HODGKIN'S LYMPHOMA


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

PHASE II TRIAL OF YTTRIUM-90-IBRITUMOMAB TIUXETAN (ZEVALIN) RADIOIMMUNOTHERAPY AFTER CYTOREDUCTION WITH ESHAP CHEMOTHERAPY IN PATIENTS WITH RELAPSED FOLLICULAR NON-HODGKIN'S LYMPHOMA


OBJECTIVES:

Primary

- To evaluate the 1-year progression-free survival of patients with relapsed stage II-IV
follicular non-Hodgkin lymphoma treated with ESHAP chemotherapy for cytoreduction
followed by yttrium Y 90 ibritumomab tiuxetan radioimmunotherapy.

- To evaluate the median time to progression in these patients.

Secondary

- To evaluate the overall and complete response rates in patients treated with this
regimen.

OUTLINE:

- ESHAP chemotherapy: Patients receive ESHAP chemotherapy comprising etoposide IV over 1
hour, methylprednisolone IV, cisplatin IV on days 1-4, and cytarabine IV over 2 hours
on day 1. Treatment repeats every 28 days for 2 courses in the absence of disease
progression or unacceptable toxicity.

- Radioimmunotherapy: Between 4-6 weeks after completion of ESHAP chemotherapy, patients
receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes
on day 1. Patients with < 25% bone marrow involvement and expected biodistribution
proceed to treatment. Patients receive rituximab IV followed by yttrium Y 90
ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of follicular non-Hodgkin lymphoma (NHL)

- Bulky stage II, stage III, or stage IV disease

- Bulky disease is defined as any tumor measuring 10.0 cm or more or
occupying ≥ one-third of the chest diameter

- In first, second, third, or fourth relapse after chemotherapy

- Unilateral or bilateral bone marrow aspirate and biopsy with cytogenetics within
the past 42 days

- Tumor CD20 positive by either flow cytometry or immunoperoxidase staining of paraffin
sections using anti-CD20 antibodies

- Bidimensionally measurable disease

- Patients with non-measurable disease in addition to measurable disease must have
all non-measurable disease assessed within the past 42 days

- No presence of CNS lymphoma

- No chronic lymphocytic leukemia

- No HIV- or AIDS-related lymphoma

- No presence of pleural effusion

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,500/μL (unless decreased counts are due to marrow involvement with NHL)

- Platelet count > 100,000/μL (unless decreased counts are due to marrow involvement
with NHL)

- Serum creatinine ≤ 2.0 mg/dL

- Creatinine clearance ≤ 50 mL/min

- Serum bilirubin ≤ 2.0 mg/dL

- No renal insufficiency or renal failure

- No known HIV positivity

- Not pregnant or nursing

- No prior malignancy except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer with 5-year disease-free status

- No impaired bone marrow reserve, including any of the following:

- Hypocellular bone marrow (cellularity ≤ 15%)

- Marked ( ≥ 10%) reduction in bone marrow precursors of one or more cell lines
(granulocytic, megakaryocytic, erythroid) (beyond that which would be expected
for the patient's age and bone marrow cellularity)

- History of failed stem cell collection

- No serious, non-malignant disease or infection which, in the opinion of the
investigator and/or sponsor, would compromise other protocol objectives

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since all prior therapy (6 weeks for rituximab) and recovered

- No prior myeloablative therapies with autologous bone marrow transplantation or
peripheral blood stem cell rescue

- No prior radioimmunotherapy

- No prior external beam radiotherapy to > 25% of active bone marrow (involved field or
regional)

- More than 4 weeks since prior major surgery, other than diagnostic surgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 1 year

Outcome Description:

To evaluate the 1-year progression-free survival (PFS) of patients with relapsed follicular non-Hodgkin's lymphoma (NHL) treated with ESHAP chemotherapy for cytoreduction (2 cycles) followed by Ibritumomab tiuxetan (Zevalin) radioimmunotherapy.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Thomas P. Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona

Authority:

United States: Food and Drug Administration

Study ID:

05-0303-04

NCT ID:

NCT00732498

Start Date:

May 2009

Completion Date:

December 2013

Related Keywords:

  • Lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

University of Arizona Cancer CenterTucson, Arizona  85724