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

NCT00057967 | Completed Phase 2 DMC

• 2 other identifiers: NU 99H8STU00012258
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treatment arm

EXPERIMENTAL

alemtuzumab

Biological: alemtuzumab

Interventions

alemtuzumab 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.

Also known as: Campath, MabCampath, Campath-1H

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Millennium Pharmaceuticals, Inc.: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (2)

Northwestern University, Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611-3013, United States

Location

Veterans Affairs Medical Center - Lakeside Chicago

Chicago, Illinois, 60611-4494, United States

Location

MeSH Terms

Conditions

Lymphoma; Mycosis Fungoides; Sezary Syndrome; Lymphoma, T-Cell, Cutaneous

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Timothy M. Kuzel, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: July 1, 2000
• Primary Completion: June 26, 2007
• Study Completion: July 26, 2010
• Last Updated: February 6, 2019

Record last verified: 2019-01

Locations

US (2)