Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: visilizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-cell Lymphomas |
| Study Start Date: | April 2001 |
| Study Completion Date: | October 2003 |
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 |
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| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| Study Chair: | Youn H. Kim, MD | Stanford University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006009 History of Changes |
| Other Study ID Numbers: | SUMC-NCI-102, CDR0000068017, NCI-102 |
| Study First Received: | July 5, 2000 |
| Last Updated: | May 14, 2013 |
| 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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013