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

• ClinicalTrials.gov Identifier: NCT00005982
• Recruitment Status: Terminated
• First Posted: January 27, 2003
• Last Update Posted: January 23, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Study Description

Brief 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

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
• Study Start Date: April 2000
• Actual Primary Completion Date: July 2004

Arms and Interventions

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.	Drug: nelarabine; Given IV; Other Names: 506U78; Arranon; GW506U78; Other: pharmacological study; Correlative studies; Other Name: pharmacological studies

Outcome Measures

Primary Outcome Measures :

1. Response rate (RR) defined as CR + PR rates [ Time Frame: Up to 4 years ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: NCI-2012-02344; ID99-213; CDR0000067970 ( Registry Identifier: PDQ (Physician Data Query) )
• First Posted: January 27, 2003
• Last Update Posted: January 23, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

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