NCT00006009

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2001

Shorter than P25 for phase_1 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

First Submitted

Initial submission to the registry

July 5, 2000

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2003

Completed
Last Updated

May 15, 2013

Status Verified

April 1, 2003

First QC Date

July 5, 2000

Last Update Submit

May 14, 2013

Conditions

LymphomaSmall Intestine Cancer

Keywords

stage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomasmall intestine lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndrome

Interventions

visilizumabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed CD3+ T-cell lymphoma for which no standard curative therapy exists * Peripheral T-cell lymphoma * Recurrent and/or progressive disease after at least 1 prior therapy * Mycosis fungoides * Stage IB/IIA * Recurrent and/or progressive disease after at least 2 prior therapies * Stage IIB-IVB * Recurrent and/or progressive disease after at least 1 prior therapy * All other T-cell lymphomas * Recurrent and/or progressive disease after at least 1 prior therapy * Evaluable disease * Any nodal site or mass lesion at least 1.5 cm in longest axis on physical exam or CT scan * Skin lesions at least 1 cm in longest axis for cutaneous lymphoma * High numbers of circulating T-cells allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 * Karnofsky 50-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 2,000/mm\^3\* * Absolute neutrophil count at least 1,000/mm\^3\* * Platelet count at least 75,000/mm\^3\* NOTE: \* Unless due to lymphoma Hepatic: * Bilirubin no greater than 2.0 times normal\* * AST/ALT no greater than 2.5 times upper limit of normal\* * Hepatitis B and C negative NOTE: \* Unless due to lymphoma Renal: * Not specified Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No other uncontrolled illness * No ongoing or active infection * No other active malignancies except basal cell skin cancer or carcinoma in situ of the cervix * HIV-1 negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * At least 60 days since prior humanized or chimeric antibody therapy Chemotherapy: * At least 3 weeks since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy Surgery: * Not specified Other: * At least 30 days since prior investigational drugs or therapies

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

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, CutaneousPrecursor T-Cell Lymphoblastic Leukemia-LymphomaImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary Syndrome

Interventions

visilizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic DiseasesLymphadenopathy

Study Officials

  • Youn H. Kim, MD

    Stanford University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

October 8, 2003

Study Start

April 1, 2001

Study Completion

October 1, 2003

Last Updated

May 15, 2013

Record last verified: 2003-04

Locations

US(1)