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Study Summary
No. 2005-0571:.......Lymphoma......Felipe Samaniego......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:
2005-0571
Study Title:Multicenter Phase II Study for ZevalinŽ in Patients with Relapsed/Refractory Indolent Lymphomas: Extranodal marginal lymphoma of MALT type, Nodal Marginal zone B-cell lymphoma, and Splenic marginal B-cell lymphoma
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Physician New Patient Referral
Name:Felipe SamaniegoPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Weekly labs x 12 weeks: Physician visits at 2,4, and 12 weeks (with completed
labs and test); F/U q 3 months x 1 year, F/U q 4 months x 13 months, then F/U q
6 months x 3 years.
Treatment
Agents:
90Y-ibritumomab tiuxetanHome Care:N/A
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this clinical research study is to find out if 90 Y ZevalinŽ (90 Y
[ibritumomab tiuxetan]) given with rituximab to help ibritumomab tiuxetan work
better may be effective in the treatment of relapsed and refractory indolent
lymphoma. The safety of this combination therapy will also be studied.
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Study Objectives / Outcomes
The Primary Objective is the Overall Response Rate (ORR).

The Secondary Objectives are:
a. The Duration of Response (DR) and Time to Treatment Progression (TTP) in all patients and in the responders.
b. Complete Responses (CR)/Complete Responses unconfirmed (CRu), and Partial Responses (PR).
c. Time to next anticancer therapy (TTNT).
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Study Status Information
Study Activation / Registration Date:04/13/2006
IRB Review and Approval Date:11/16/2005
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:35
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from acute toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy.

2) Previously treated patients with a histology of refractory/relapsed indolent lymphomas including: (a) Extranodal marginal lymphoma of MALT type; (b) Nodal Marginal zone B-cell lymphoma (+/- monocytoid cells); (c) Splenic marginal B-cell lymphoma (+/- villous lymphocytes).

3) Signed informed consent

4) Age >/= 18 years

5) Expected survival >/= 3 months

6) Pre-study Zubrod performance status of 0, 1, or 2

7) Acceptable hematologic status within two weeks prior to patient registration, including: (a) Absolute neutrophil count ([segmented neutrophils + bands] x total WBC) >/= 1,500/mm^3; (b) Platelet counts >/= 100,000/mm^3.

8) Female patients who are not pregnant or lactating

9) Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician)

10) Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post treatment toxicities observed

11) Patients determined to have < 25% bone marrow involvement with lymphoma within six weeks of registration (define measurement of a bone marrow aspirate or biopsy) (This criteria must be strictly met for adequate patient safety.)

12) Patient should have at least one lesion measuring >/= 2 cm in a single dimension.

Exclusion Criteria:1) Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue.

2) Platelet count< 100,000 cells/mm^3.

3) Presence of hypocellular bone marrow.

4) Patients with history of failed stem cell collection.

5) Prior radioimmunotherapy

6) Presence of CNS lymphoma

7) Patients with HIV.

8) Patients with pleural effusion

9) Patients with abnormal liver function: total bilirubin > 2.0 mg/dL

10) Patients with abnormal renal function: serum creatinine > 2.0 mg/dL

11) Patients who have received prior external beam radiation therapy to > 25% of active bone marrow (involved field or regional)

12) Patients who have received short-acting growth factor support (Leukine, Neupogen, Procrit) within 2 weeks prior to treatment or long-acting growth-factor support (Aranesp), Neulasta) within 4 weeks prior to treatment.

13) Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives

14) Major surgery, other than diagnostic surgery, within four weeks

15) Evidence of transformation in the latest biopsy

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Links
Registration Number: NCT00493454
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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