Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

May 14, 2013 updated by: Stanford University

A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Youn H. Kim, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

October 7, 2003

First Posted (Estimate)

October 8, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMC-NCI-102
  • CDR0000068017 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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