Denileukin Diftitox in Treating Patients With Adult T-Cell Leukemia/Lymphoma - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00138190

Purpose

RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry cancer-killing substances directly to adult T-cell leukemia/lymphoma cells.

PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with adult T-cell leukemia/lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: denileukin diftitox	Phase II

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

Drug Information available for: Denileukin diftitox

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Phase II Study of the Efficacy and Toxicity of Ontak® (Denileukin Diftitox) in the Therapy of Adult T-Cell Leukemia

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

Primary Outcome Measures:

Response rate after 2 courses of treatment and then after every course for 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety after 2 courses of treatment and then after every 4 courses for 1 year [ Designated as safety issue: Yes ]

Estimated Enrollment:	29
Study Start Date:	July 2005
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the antitumor activity of denileukin diftitox, in terms of response rate, time to disease progression, and overall survival, in patients with Tac-expressing HTLV-1-associated adult T-cell leukemia/lymphoma.

Secondary

Determine the safety of this drug in these patients.

OUTLINE: This is a non-randomized study.

Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 14 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses of treatment beyond CR.

After completion of study treatment, patients are followed at 4 weeks, every 1-3 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 1-2½ years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed Tac-expressing adult T-cell leukemia/lymphoma (ATL)
- All stages allowed, including chronic, lymphomatous, or acute (ATL)
HTLV-1 antibody positive
More than 10% of malignant cells must express CD25
Measurable disease, defined as > 10% abnormal (i.e., TAC homogenous strongly expressing) peripheral blood mononuclear cells
No smoldering ATL
No symptomatic leukemic meningitis* NOTE: *Patients with ATL and another HTLV-1-associated disease (e.g., tropical spastic paraparesis) are eligible

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

More than 2 months

Hematopoietic

Granulocyte count ≥ 1,000/mm^3
Platelet count ≥ 50,000/mm^3

Hepatic

AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 3.0 mg/dL
Albumin ≥ 2.5 g/dL

Renal

Creatinine < 2.0 mg/dL

Cardiovascular

No myocardial infarction within the past 6 months
No severe coronary artery disease

Other

Not pregnant
No nursing during and for 3 months after completion of study treatment
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study treatment
HIV negative
No other serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior denileukin diftitox
No concurrent monoclonal antibodies
No concurrent gammaglobulin

Chemotherapy

At least 3 weeks since prior cytotoxic chemotherapy for ATL
No concurrent chemotherapy

Endocrine therapy

Prior or concurrent corticosteroids allowed

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent drugs that would affect lymphocytes
No other concurrent investigational anticancer drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138190

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John E. Janik, 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

Featured trial article 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 Edward Janik )
Study ID Numbers:	CDR0000440050, NCI-05-C-0185, NCI-P6591
Study First Received:	August 29, 2005
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00138190 History of Changes
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia-Lymphoma, Adult T-Cell
Recurrence
Leukemia
Lymphatic Diseases
Interleukin-2

Analgesics, Non-Narcotic
Denileukin diftitox
Leukemia, T-Cell
Peripheral Nervous System Agents
Analgesics
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

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

Sensory System Agents
Analgesics, Non-Narcotic
Interleukin-2
Therapeutic Uses
Denileukin diftitox
Leukemia, T-Cell
Peripheral Nervous System Agents
Analgesics
Lymphoproliferative Disorders
Central Nervous System Agents
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009