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| ID | Type | Description | Link |
|---|---|---|---|
| NU 99H8 | Other Identifier | Northwestern University | |
| STU00012258 | Other Identifier | Northwestern University IRB |
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
| Genzyme, a Sanofi Company | INDUSTRY |
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RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome.
OBJECTIVES:
OUTLINE: Patients receive alemtuzumab IV over 2 hours three times per week. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | alemtuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alemtuzumab | Biological | Will be administered as a two-hour IV infusion with a target dose of 30 milligrams three times a week for a maximum of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome | Response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome will be assessed by medical photograph (skin lesion) measurements or by CT scan for internal lesions upon study entry, weekly while on study, then once when patient goes off study | At baseline, weekly while on treatment, then once when patient goes off study |
| Collect data on toxicity associated with Campath-1H therapy | Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests | At baseline and then every 2 weeks while on therapy |
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DISEASE CHARACTERISTICS:
Histologically confirmed mycosis fungoides or Sézary syndrome
Measurable disease
Must have failed at least 1 prior systemic therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M. Kuzel, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611-3013 | United States | ||
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Veterans Affairs Medical Center - Lakeside Chicago |
| Chicago |
| Illinois |
| 60611-4494 |
| United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |