A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas
18 Years
N/A
Both
Lymphoma, Small Intestine Cancer
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 Center | Stanford, California 94305-5408 |
