Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006009
• Other study ID #: SUMC-NCI-102
• Secondary ID: CDR0000068017NCI
• Status: Completed
• Phase: Phase 1
• First received: July 5, 2000
• Last updated: May 14, 2013
• Start date: April 2001
• Est. completion date: October 2003

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Small Intestine Cancer

Intervention

Biological:
• visilizumab

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,