Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma - Full Text View

Sponsors and Collaborators:	Stanford University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006009

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: monoclonal antibody HuM291	Phase I

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Fungal Infections Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Visilizumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Study Start Date:

April 2001

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Youn H. Kim, MD

Stanford University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068017, SUMC-NCI-102, NCI-102
Study First Received:	July 5, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006009 History of Changes
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

Study placed in the following topic categories:

Immunologic Factors
Gastrointestinal Diseases
Sezary Syndrome
Mycosis Fungoides
Ileal Diseases
Antibodies, Monoclonal
Lymphoma, Small Cleaved-cell, Diffuse
Duodenal Neoplasms
Leukemia
Mycoses
Ileal Neoplasms
Cutaneous T-cell Lymphoma
Lymphoma, T-Cell
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Large-cell

Lymphoma
Duodenal Diseases
Immunoglobulins
Jejunal Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia-Lymphoma, Adult T-Cell
Immunoblastic Lymphadenopathy
Intestinal Diseases
Recurrence
Intestinal Neoplasms
Lymphatic Diseases
Antibodies
Digestive System Diseases

Additional relevant MeSH terms:

Immunologic Factors
Gastrointestinal Diseases
Physiological Effects of Drugs
Ileal Diseases
Duodenal Neoplasms
Antibodies, Monoclonal
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Lymphoma, T-Cell
Lymphoma
Duodenal Diseases
Jejunal Neoplasms
Immunoproliferative Disorders

Neoplasms by Histologic Type
Digestive System Neoplasms
Immune System Diseases
Intestinal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Lymphatic Diseases
Neoplasms
Antibodies
Digestive System Diseases
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on July 02, 2009