506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma - Full Text View

Purpose

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma

Condition	Intervention	Phase
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome	Drug: nelarabine Other: pharmacological study	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics: Sézary syndrome mycosis fungoides

MedlinePlus related topics: Lymphoma

Drug Information available for: Nelarabine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Mycosis Fungoides Cutaneous T-cell Lymphoma Sezary Syndrome

U.S. FDA Resources

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

Primary Outcome Measures:

Response rate (RR) defined as CR + PR rates [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]


Enrollment:	35
Study Start Date:	April 2000
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment (nelarabine) Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Drug: nelarabine Given IV Other Names: 506U78 Arranon GW506U78 Other: pharmacological study Correlative studies Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.

II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- Large cell transformation of cutaneous T-cell lymphoma allowed
No active CNS disease
Performance status - Zubrod 0-2
Absolute neutrophil count at least 1,000/mm^3*
Platelet count at least 100,000/mm^3*
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGPT no greater than 2.5 times ULN
Creatinine clearance greater than 50 mL/min
No history of symptomatic cardiac dysfunction
No history of pericardial effusion
HIV negative
No grade 2 or greater sensory or motor neuropathy
No history of seizures
No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
No medical, psychiatric, or social condition that would preclude study
No other concurrent serious illness or active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No prior stem cell or bone marrow transplantation (BMT)
No more than 1 prior immunotherapy regimen
No more than 3 prior systemic regimens with denileukin diftitox
At least 3 weeks since prior biologic therapy
No concurrent BMT
No prior 506U78
No more than 3 prior systemic chemotherapy regimens comprising any of the following:
- Oral methotrexate
- Topical mechlorethamine
At least 3 weeks since prior chemotherapy
No other concurrent chemotherapy
At least 3 weeks since prior anticancer endocrine therapy
No concurrent topical or systemic steroids
At least 3 weeks since prior radiotherapy
No more than 3 prior systemic regimens comprising any of the following:
- Total skin electron beam therapy
- Spot radiotherapy
No more than 3 prior systemic regimens comprising any of the following:
- Oral retinoids
- Ultraviolet therapy (PUVA)
At least 3 weeks since prior anticancer therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005982

Locations


United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Andre Goy	M.D. Anderson Cancer Center

More Information


Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005982 History of Changes
Other Study ID Numbers:	NCI-2012-02344 ID99-213 CDR0000067970
Study First Received:	July 5, 2000
Last Updated:	January 22, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous	Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016