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

NCT ID: NCT00057967

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2010-07-26

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

alemtuzumab

Group Type: EXPERIMENTAL

alemtuzumab

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Campath; MabCampath; Campath-1H

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy M. Kuzel, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU 99H8

Identifier Type: OTHER

Identifier Source: secondary_id

STU00012258

Identifier Type: OTHER

Identifier Source: secondary_id

NU 99H8

Identifier Type: -

Identifier Source: org_study_id