Alemtuzumab in Treating Patients With HTLV-1 Associated Adult T-Cell Leukemia/Lymphoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064155

Purpose

RATIONALE: Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with HTLV-1 associated adult T-cell leukemia/lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: alemtuzumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of the Efficacy and Toxicity of Campath-1H in the Therapy of Adult T-Cell Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Campath Alemtuzumab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Saturation of CD52 every month during treatment, monthly for 3 months, and then every 3 months for a year [ Designated as safety issue: No ]

Estimated Enrollment:	29
Study Start Date:	May 2003
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the efficacy of alemtuzumab in patients with HTLV-1-associated adult T-cell leukemia/lymphoma.
Determine the time course of alemtuzumab saturation in these patients.
Determine the toxicity of this drug in these patients.

OUTLINE: This is a nonrandomized study.

Each patient receives escalating doses of alemtuzumab IV once daily until the target dose is reached and tolerated. Patients then receive the target dose of alemtuzumab IV over 2 hours 3 times weekly for a total of 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly until the CD4 count has recovered and then every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 9-29 patients will be accrued for this study within 2.5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adult T-cell leukemia (ATL)/lymphoma
- More than 10% of malignant cells must express CD52 and CD25
- All stages of tac-expressing ATL are eligible, including chronic or acute disease
- No smoldering ATL
HTLV-1-associated disease
- Must have serum antibodies directed to HTLV-1
Measurable disease
- Greater than 10% abnormal (i.e., Tac homogenous strongly expressing) peripheral blood mononuclear cells considered to be measurable disease
No symptomatic leukemic meningitis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

More than 2 months

Hematopoietic

Granulocyte count at least 1,000/mm^3
Platelet count at least 50,000/mm^3

Hepatic

SGOT and SGPT no greater than 2.5 times upper limit of normal
Bilirubin no greater than 3.0 mg/dL

Renal

Creatinine less than 3.0 mg/dL

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
HIV negative
Other concurrent HTLV-1-associated diseases (e.g., tropical spastic paraparesis) are allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior alemtuzumab
No other concurrent monoclonal antibody therapy
No concurrent gammaglobulins
No concurrent biological response modifiers (e.g., interferon or similar agents)

Chemotherapy

More than 3 weeks since prior cytotoxic chemotherapy for ATL
No concurrent FDA-approved or investigational anticancer chemotherapy

Endocrine therapy

Concurrent stable dose corticosteroids (administered for at least 3-4 weeks) allowed provided there is no evidence of tumor response

Radiotherapy

Not specified

Surgery

Not specified

Other

No other concurrent investigational anticancer agents
No concurrent zidovudine
No concurrent drug that affects lymphocytes, except corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064155

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

John C. Morris, MD

NCI - Metabolism Branch;MET

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NCI - Metabolism Branch;MET ( John Charles Morris )
Study ID Numbers:	CDR0000309057, NCI-03-C-0194, NCI-4553
Study First Received:	July 8, 2003
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00064155 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:

Leukemia, Lymphoid
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Leukemia-Lymphoma, Adult T-Cell
Pharmacologic Actions
Leukemia

Lymphatic Diseases
Neoplasms
Therapeutic Uses
Alemtuzumab
Leukemia, T-Cell
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 30, 2009