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

Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005982
• Other study ID #: NCI-2012-02344
• Secondary ID: ID99-213CDR00000
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: January 22, 2013
• Start date: April 2000

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycosis Fungoides
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Sezary Syndrome

Intervention

Drug:
• nelarabine
Given IV

Other:
• pharmacological study
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (RR) defined as CR + PR rates		Up to 4 years	No