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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00057967
Enrollment
37
Registered
2003-04-09
Start date
2000-07-31
Completion date
2010-07-26
Last updated
2019-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

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

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.

Interventions

BIOLOGICALalemtuzumab

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.

Sponsors

Millennium Pharmaceuticals, Inc.
CollaboratorINDUSTRY
Genzyme, a Sanofi Company
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determine response rate associated with Campath-1H therapy in patients with relapsed Mycosis Fungoides/Sezary SyndromeAt baseline, weekly while on treatment, then once when patient goes off studyResponse 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 therapyAt baseline and then every 2 weeks while on therapyToxicity of this drug will be assessed upon study entry and then every 2 weeks while on therapy by blood tests

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026