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

• ClinicalTrials.gov Identifier: NCT00057967
• Recruitment Status: Completed
• First Posted: April 9, 2003
• Last Update Posted: February 6, 2019
• Sponsor: Northwestern University
• Collaborators: Millennium Pharmaceuticals, Inc.; Genzyme, a Sanofi Company
• Information provided by (Responsible Party): Northwestern University

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Biological: alemtuzumab	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome
• Study Start Date: July 2000
• Actual Primary Completion Date: June 26, 2007
• Actual Study Completion Date: July 26, 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment arm; alemtuzumab	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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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
2. Collect data on toxicity associated with Campath-1H therapy [ Time Frame: At baseline and then every 2 weeks while on therapy ]
   Toxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Illinois

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, United States, 60611-3013

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States, 60611-4494

Sponsors and Collaborators

Northwestern University

Millennium Pharmaceuticals, Inc.

Genzyme, a Sanofi Company

Investigators

• Principal Investigator: Timothy M. Kuzel, MD; Northwestern University

More Information

• Responsible Party: Northwestern University
• ClinicalTrials.gov Identifier: NCT00057967
• Other Study ID Numbers: NU 99H8; NU 99H8 ( Other Identifier: Northwestern University ); STU00012258 ( Other Identifier: Northwestern University IRB )
• First Posted: April 9, 2003
• Last Update Posted: February 6, 2019
• Last Verified: January 2019

Keywords provided by Northwestern University:

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

Additional relevant MeSH terms:

Mycoses; Lymphoma; Mycosis Fungoides; Sezary Syndrome; Syndrome; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease; Pathologic Processes; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Alemtuzumab; Antineoplastic Agents, Immunological; Antineoplastic Agents