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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Timothy Kuzel, Northwestern University
ClinicalTrials.gov Identifier:
NCT00057967
First received: April 7, 2003
Last updated: October 28, 2013
Last verified: October 2013

April 7, 2003
October 28, 2013
July 2000
August 2014   (final data collection date for primary outcome measure)
  • Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome [ Time Frame: At baseline, weekly while on treatment, then once when patient goes off study ] [ Designated as safety issue: No ]
    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 [ Time Frame: At baseline and then every 2 weeks while on therapy ] [ Designated as safety issue: Yes ]
    Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests
Not Provided
Complete list of historical versions of study NCT00057967 on ClinicalTrials.gov Archive Site
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Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome

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:

  • 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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Biological: alemtuzumab
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.
Other Names:
  • Campath
  • MabCampath
  • Campath-1H
Experimental: Treatment arm
alemtuzumab
Intervention: Biological: alemtuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
37
August 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057967
NU 99H8, NU 99H8, STU00012258
Yes
Timothy Kuzel, Northwestern University
Northwestern University
  • Millennium Pharmaceuticals, Inc.
  • Genzyme, a Sanofi Company
Principal Investigator: Timothy M. Kuzel, MD Northwestern University
Northwestern University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP