Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

NCT00193505 | Completed Phase 2

• 2 other identifiers: SCRI LYM 27106-P092
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Conditions

Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (1)

• complete response rate

Secondary Outcomes (2)

• progression-free survival

• overall survival

Interventions

Ifosfamide DRUG

Carboplatin DRUG

Etoposide DRUG

Rituximab DRUG

90Y Zevalin DRUG

Eligibility Criteria

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

You may qualify if:

• To be included in this study, you must meet the following criteria:
• Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
• Persistent lymphoma after one or two previous chemotherapy regimens
• Patients should not be considered candidates for high-dose chemotherapy
• Ability to perform activities of daily living with assistance
• Measurable or evaluable disease
• Age \> 18 years
• Adequate bone marrow, liver and kidney function

You may not qualify if:

• You cannot participate in this study if any of the following apply to you:
• Patients with impaired bone marrow reserve
• Female patients who are pregnant or lactating
• Serious active infection at the time of treatment
• Any other serious underlying condition
• Brain or meningeal) with lymphoma
• HIV or AIDS-related lymphoma
• Received external beam radiation therapy to \> 25% of active bone marrow.
• History of other cancers, either active or treated

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Biogen: collaborator

Study Sites (1)

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Ifosfamide; Carboplatin; Etoposide; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John D. Hainsworth, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: May 3, 2011

Record last verified: 2011-05

Locations

US (1)