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

Lymphoma Clinical Trial

Official title:

Phase II Trial Of Campath-1H In Patients With Relapsed/Refractory Advanced Mycosis Fungoides or Sezary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057967
• Other study ID #: NU 99H8
• Secondary ID: NU 99H8STU000122
• Status: Completed
• Phase: Phase 2
• Start date: July 2000
• Est. completion date: July 26, 2010

Study information

• Verified date: January 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 26, 2010
• Est. primary completion date: June 26, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Genzyme, a Sanofi Company, Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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