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Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alemtuzumab
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent mycosis fungoides/Sezary syndrome, 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 cutaneous T-cell non-Hodgkin lymphoma, 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed mycosis fungoides or Sézary syndrome Stage IB-IVB Measurable disease One or more indicator lesions No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy Generalized erythrodermia patients with evaluable disease only are allowed Must have failed at least 1 prior systemic therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR WHO 0-2 Life expectancy At least 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal Creatinine no greater than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No acute infection requiring intravenous antibiotics No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior topical steroids Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy (local control or palliative) No concurrent radiotherapy to any lesion Surgery Recovered from prior major surgery Other Recovered from prior therapy No other concurrent proven or investigational antineoplastic agents

Sites / Locations

  • Northwestern University, Northwestern Medical Faculty Foundation
  • Veterans Affairs Medical Center - Lakeside Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

alemtuzumab

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
February 5, 2019
Sponsor
Northwestern University
Collaborators
Millennium Pharmaceuticals, Inc., Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00057967
Brief Title
Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
Official Title
Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
June 26, 2007 (Actual)
Study Completion Date
July 26, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
Millennium Pharmaceuticals, Inc., Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab. Determine the toxicity of this drug in these patients. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent mycosis fungoides/Sezary syndrome, 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 cutaneous T-cell non-Hodgkin lymphoma, 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
alemtuzumab
Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Other Intervention Name(s)
Campath, MabCampath, Campath-1H
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome
Description
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
Time Frame
At baseline, weekly while on treatment, then once when patient goes off study
Title
Collect data on toxicity associated with Campath-1H therapy
Description
Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
Time Frame
At baseline and then every 2 weeks while on therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed mycosis fungoides or Sézary syndrome Stage IB-IVB Measurable disease One or more indicator lesions No prior radiotherapy to areas of measurable disease unless there is clear disease progression at the site or measurable disease outside the area of prior radiotherapy Generalized erythrodermia patients with evaluable disease only are allowed Must have failed at least 1 prior systemic therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR WHO 0-2 Life expectancy At least 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal Creatinine no greater than 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No acute infection requiring intravenous antibiotics No other prior neoplasm except treated squamous cell or basal cell skin cancer, treated carcinoma in situ of the cervix, or other cancer that received surgical treatment only from which patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior topical steroids Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy (local control or palliative) No concurrent radiotherapy to any lesion Surgery Recovered from prior major surgery Other Recovered from prior therapy No other concurrent proven or investigational antineoplastic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M. Kuzel, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University, Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4494
Country
United States

12. IPD Sharing Statement

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Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome

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