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Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Latin American Cooperative Onco-Haematology Group - Peru.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Latin American Cooperative Onco-Haematology Group - Peru
ClinicalTrials.gov Identifier:
NCT00157274
First received: September 7, 2005
Last updated: April 2, 2007
Last verified: September 2005
History of Changes
  Purpose

The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.


Condition Intervention Phase
Mycosis Fungoides
Sezary Syndrome
 Drug: alemtuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

Resource links provided by NLM:

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Further study details as provided by Latin American Cooperative Onco-Haematology Group - Peru:

Primary Outcome Measures:
  • Overall response
  • Time to relapse
  • Event free survival

Secondary Outcome Measures:
  • Toxicity

Estimated Enrollment: 20
Study Start Date: July 2005
Estimated Study Completion Date: July 2008
Detailed Description:
  • 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
  • Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
  • Follow up for one year after last cycle of alemtuzumab.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above 18 years old
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Liver and renal function test less than twice upper label
  • No active infection
  • Written informed consent
  • One to three regimens of previous chemotherapies

Exclusion Criteria:

  • Abnormal renal or hepatic function
  • Mycosis fungoides/Sezary syndrome in transformation
  • HIV +
  • HTLV-1 +
  • Pregnancy
  • Lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00157274

Contacts
Contact: Julia M Huamani, MD 511-2227020 juliahuamaniz@yahoo.es

Locations
Peru
Schering Peruana S.A. Recruiting
Lima, Peru, 511
Contact: Jesus A Arones, MD     99480078     alfredo_arones@hotmail.com    
Sponsors and Collaborators
Latin American Cooperative Onco-Haematology Group - Peru
Investigators
Principal Investigator: Brady E Beltran, MD LACOGH - PERU
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00157274     History of Changes
Other Study ID Numbers: MF/SS
Study First Received: September 7, 2005
Last Updated: April 2, 2007
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by Latin American Cooperative Onco-Haematology Group - Peru:
Alemtuzumab
Mycosis fungoides
Sezary

Additional relevant MeSH terms:
Mycoses
Mycosis Fungoides
Sezary Syndrome
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Campath 1G
Antibodies, Neoplasm
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013