Radioimmunotherapy With 90Y Zevalin for Orbital Lymphoma

NCT00387023 | Completed Results

• 1 other identifier: 2003-0696
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To evaluate the efficacy of Zevalin for the treatment of low-grade follicular Non-Hodgkin's lymphoma of the orbit or mucosa-associated lymphoid tissue (MALT) of conjunctiva using radiographic imaging, clinical examination (slit lamp biomicroscopy and external examination of the conjunctiva), and external photography whenever possible.
2. 2.To establish the safety profile in this patient population using clinical examination including slit lamp biomicroscopy, and evaluation of the tear film with Schirmer's test.
3. 3.To establish the dosimetry for Zevalin in the orbit in the first 3 patients who agree to undergo dosimetry.

Conditions

Non-Hodgkin's Lymphoma; Lymphoma

Keywords

Non-Hodgkin's Lymphoma; Orbital Lymphoma; Rituximab; Rituxan; Zevalin; Ibritumomab tiuxetan; IDEC-Y2B8; Eye

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response (CR) or Partial Response (PR)

  Tumor response to therapy measured by tumor size as measured radiographically at baseline and at three months from baseline. Tumor response classified as complete response (CR) or partial response (PR), or stable disease (SD), or progressive disease (PD) using International Workshop Standardized Response Criteria (IWC) for Non-Hodgkin's Lymphomas. If the orbital/ocular adnexal lymphoma was not evaluable radiographically, clinical evaluation using slit lamp biomicroscopy was used to assess PR or CR.

  3 months

Study Arms (1)

Zevalin + Rituximab

EXPERIMENTAL

Rituximab 250 mg/m\^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

Drug: Rituximab; Drug: Zevalin

Interventions

Rituximab DRUG

250 mg/m\^2 IV over 4-6 hours for 2 weeks.

Also known as: Rituxan

Zevalin + Rituximab

Zevalin DRUG

5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.

Also known as: Ibritumomab tiuxetan, IDEC-Y2B8

Zevalin + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven diagnosis of low-grade Non-Hodgkin's follicular lymphoma of the orbit or MALT of the conjunctiva/orbit. The orbit/conjunctiva has to be the primary or predominant site of involvement or if there is a previous history of systemic involvement, the orbit/conjunctiva should be the only site of new recurrence.
• No anti-cancer therapy for three weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
• An Institutional Review Board (IRB)-approved signed informed consent
• Age \>18 years. This is justified since low-grade non-Hodgkin's lymphoma of the orbit is extremely rare to non-existent in the pediatric population
• Expected survival of \>3 months
• Pre-study performance status of 0, 1, or 2 according to the WHO
• Acceptable hematologic status within two weeks prior to patient registration, including: a) Absolute neutrophil count (\[segmented neutrophils + bands\] x total WBC)\> 1500/mm3 b) Total lymphocyte count \< 5,000/mm3 for patients with small lymphocytic lymphoma (IWFA) c) Platelet counts\> 150,000/mm3, these patients will receive a dose of 0.4 mCi/kg of Zevalin d) Platelet counts from 100,00/mm3 to 149,000/mm3, these patients will receive a 0.3mCi/kg dose of Zevalin
• Female patients who are not pregnant or lactating
• Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however abstinence is not an acceptable method)
• Patients previously on Phase II drugs are eligible 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
• Patients determined to have less than 25% bone marrow involvement with lymphoma within six weeks of registration (based on a bone marrow biopsy). (This criteria must be strictly met for adequate patient safety.)

You may not qualify if:

• Patients with impaired bone marrow reserve, as indicated by one or more of the following: a) Prior myeloablative therapies with autologous bone marrow transplantation (ABMT) or peripheral blood stem cell (PBSC) rescue b) Platelet count \< than 100,000 cells/mm3 c) Hypocellular bone marrow (less than 15% cellularity) d) Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid)
• Prior radioimmunotherapy
• Presence of central nervous system (CNS) lymphoma
• Patients with HIV or AIDS-related lymphoma
• Patients with small lymphocytic lymphoma (IWF A) - who have a total lymphocyte count \> 5,000/mm3
• Patients with pleural effusion
• Patients with abnormal liver function: total bilirubin \> 2.0 mg/dL
• Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL
• Patients who have received prior external beam radiation therapy to \> 25% of active bone marrow (involved field or regional)
• Patients who have received Granulocyte colony-stimulating factor (G-CSF or GM-CSF) therapy within two weeks prior to treatment
• Serious nonmalignant disease or infection which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives
• Major surgery, other than diagnostic surgery, within four weeks

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Biogen: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma; Orbital lymphoma

Interventions

Rituximab; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bita Esmaeli, MD / Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Bita Esmaeli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: February 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: November 18, 2013
• Results First Posted: November 18, 2013

Record last verified: 2013-09

Locations

US (1)