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

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

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

Study Overview

• Status: Terminated
• Conditions: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome
• Intervention / Treatment: Other: pharmacological study; Drug: nelarabine

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: pharmacological study; Correlative studies; Other Names: pharmacological studies; Drug: nelarabine; Given IV; Other Names: Arranon; 506U78; GW506U78

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate (RR) defined as CR + PR rates	Up to 4 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): July 1, 2004

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 22, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Disease Attributes; Bacterial Infections and Mycoses; Lymphoma; Recurrence; Mycoses; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome
• Other Study ID Numbers: NCI-2012-02344; ID99-213; CDR0000067970 (Registry Identifier: PDQ (Physician Data Query))