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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Small Intestine Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Youn H. Kim, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

SUMC-NCI-102

NCT ID:

NCT00006009

Start Date:

April 2001

Completion Date:

October 2003

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Stanford University Medical CenterStanford, California  94305-5408