Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

UCN-01 in Treating Patients With Relapsed or Refractory Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 7 and over NCI NCI-04-C-0173 NCI-6070, 6070, NCT00085319

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Objectives

1. Determine the clinical response, progression-free survival, and overall survival of patients with relapsed or refractory systemic anaplastic large cell or mature T-cell lymphoma treated with UCN-01.
2. Determine the effect of this drug on anaplastic lymphoma kinase expression in these patients.
3. Determine the effects of this drug on soluble TAC (CD25) in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed diagnosis of 1 of the following:
  • Anaplastic large cell lymphoma
    • Systemic disease
    • T or null phenotype
  • Mature T-cell lymphoma of 1 of the following subtypes:
    • Peripheral T-cell lymphoma, unspecified
    • Adult T-cell lymphoma
    • Extranodal NK/T-cell lymphoma (nasal type)
    • Enteropathy-type T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    • Subcutaneous panniculitis-like T-cell lymphoma
    • Angioimmunoblastic T-cell lymphoma



• Relapsed or refractory disease



• Measurable or evaluable disease



• Must have received at least 1 prior regimen for lymphoma



• Ineligible for, or refused potentially curative therapy (i.e., transplantation)



• No active CNS lymphoma

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• More than 3 weeks since prior systemic cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• No concurrent steroids as antiemetics

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from prior therapy to grade ≤ 1
• No other concurrent investigational agents

Patient Characteristics:

Age

• 7 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 500/mm³*
• Platelet count ≥ 50,000/mm³*

 [Note: *Unless hematological impairments are caused by organ involvement by lymphoma]

Hepatic

• AST ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN (patients with elevations consistent with Gilbert's disease allowed provided they have a normal direct bilirubin)

Renal

• Creatinine ≤ 1.5 mg/dL (1.2 mg/dL for patients 12 to 14 years of age)

  OR

• Creatinine clearance > 50 mL/min (60 mL/min for pediatric patients)

Cardiovascular

• No symptomatic cardiac disease
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No exertional angina pectoris
• No cardiac arrhythmia

Pulmonary

• No symptomatic pulmonary disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 8 weeks after study participation
• HIV negative
• No history of diabetes mellitus requiring insulin therapy

Expected Enrollment

A total of 18-37 patients (9-18 per stratum) will be accrued for this study within 3 years.

Outcomes

Clinical response, progression-free survival, and overall survival at the end of and for 5 years following study treatment

Effect on anaplastic lymphoma kinase (ALK) expression in patients with anaplastic large cell lymphoma (ALCL) during pre-treatment and after course 1
Effect on soluble TAC (CD25) during and periodically following study treatment
Evaluate mature T-cell lymphoma malignant cells as measured by cDNA microarray at pre-treatment and after course 1

Outline

Patients are stratified according to disease (anaplastic large cell lymphoma vs mature T-cell lymphoma).

Patients receive UCN-01 IV over 72 hours on days 1-3 of course 1 and over 36 hours on days 1-2 of all subsequent courses. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research-Medical Oncology

Kieron Dunleavy, MD, Protocol chair		Ph: 301-435-1007
Alan Wayne, MD, Protocol co-chair		Ph: 301-496-4256

U.S.A.
Maryland
	Bethesda
	NCI - Center for Cancer Research-Medical Oncology
		Clinical Trials Office - NCI - Center for Cancer Research	Ph:  888-624-1937
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Featured trial article
Web site for additional information

Registry Information
Official Title		Phase II Study of UCN-01 in Relapsed or Refractory Systemic Anaplastic Large Cell and Mature T-Cell Lymphomas
Trial Start Date		2004-04-27
Trial Completion Date		2011-05-12 (estimated)
Registered in ClinicalTrials.gov		NCT00085319
Date Submitted to PDQ		2004-04-27
Information Last Verified		2008-10-27