search
Back to results

Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

Primary Purpose

Lymphoma, Small Intestine Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
visilizumab
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
May 14, 2013
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006009
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
Official Title
A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas. Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population. Determine the response in these patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 1 month and then monthly for 3 months. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Intestine Cancer
Keywords
stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
visilizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn H. Kim, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

We'll reach out to this number within 24 hrs