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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00057967

Collaborator

Millennium Pharmaceuticals, Inc. (Industry), Genzyme, a Sanofi Company (Industry)

Enrollment

Locations

Arm

120.8

Duration (Months)

18.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jul 1, 2000

Actual Primary Completion Date :

Jun 26, 2007

Actual Study Completion Date :

Jul 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

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

Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary Syndrome [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
Collect data on toxicity associated with Campath-1H therapy [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois	United States	60611-3013
2	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494