Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006009
First received: July 5, 2000
Last updated: May 14, 2013
Last verified: April 2003
  Purpose

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.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Biological: visilizumab
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2001
Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006009

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Sponsors and Collaborators
Stanford University
Investigators
Study Chair: Youn H. Kim, MD Stanford University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006009     History of Changes
Other Study ID Numbers: SUMC-NCI-102, CDR0000068017, NCI-102
Study First Received: July 5, 2000
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014