Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

NCT ID: NCT00006009

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2003-10-31

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.

Conditions

Lymphoma; Small Intestine Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

visilizumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Principal Investigators

Youn H. Kim, MD

Role: STUDY_CHAIR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

CDR0000068017

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-102

Identifier Type: -

Identifier Source: secondary_id

SUMC-NCI-102

Identifier Type: -

Identifier Source: org_study_id