NCT00066508

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2.2 years

First QC Date

August 6, 2003

Last Update Submit

January 7, 2013

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (combined complete response and partial response)

Secondary Outcomes (4)

  • Safety

  • Tolerability

  • Time to disease progression

  • Possible mechanism of resistance

Interventions

bortezomibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following: * Relapsed after prior high-dose chemotherapy with stem cell support * Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support * Measurable disease * At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan * No primary or secondary CNS lymphoma * No HIV-related lymphoma * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * Hemoglobin at least 9 g/dL * Absolute neutrophil count at least 1,000/mm\^3 * No colony-stimulating factors within 4 weeks before obtaining this result * Platelet count at least 50,000/mm\^3 * No platelet transfusion within 4 weeks before obtaining this result Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * No active hepatitis B or C viral infection Renal * Creatinine no greater than 2 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular * No myocardial infarction within the past 6 months * No evidence of acute ischemia or new conduction system abnormalities on EKG * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Sodium greater than 130 mEq/L * HIV negative * No ongoing or active infection * No other concurrent uncontrolled illness that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * See Chemotherapy * At least 4 weeks since prior immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery unless fully recovered Other * Recovered from prior therapy * No other concurrent investigational agents * No other concurrent investigational or commercial agents or therapies to treat the malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sven De Vos, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

May 1, 2003

Primary Completion

July 1, 2005

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(1)