Protocol Number: 04-C-0173

Title:

Phase II Study of UCN-01 in Relapsed or Refractory Systemic Anaplastic Large Cell and Mature T-Cell Lymphomas

Number:

04-C-0173

Summary:

This study will examine the effects of an experimental drug called UCN-01 on T-cell lymphomas. UCN-01 inhibits the growth of several different tumor cells, and, in laboratory studies, it has worked particularly well on tumor cells taken from patients with T cell lymphomas.

Patients 9 years of age and older with T cell lymphoma that has relapsed or is not responding to chemotherapy may be eligible for this study. Candidates will be screened with a medical histories and physical examinations, blood and urine tests, electrocardiograms, chest x-rays, and CT scans of the chest, abdomen and pelvis. Additional tests may be done if clinically indicated, such as PET scans, bone marrow aspirations and biopsies, lumbar punctures (spinal taps) and CTs or MRI scans if there is evidence of central nervous system disease.

Participants are given UNC-01 in 28-day treatment cycles. The drug is given by vein in a continuous 72-hour infusion on the first cycle and in 36-hour infusions on subsequent cycles. The total number of cycles patients receive depends on how well the tumor responds to the drug and how well the patient tolerates drug side effects. Patients who do well may receive treatment for up to 1 year. Patients whose disease worsens with treatment or who do not tolerate the therapy are taken off the study.

Some or all of the screening tests are repeated periodically during the course of treatment to monitor safety and treatment response. X-rays and scans are done every other treatment cycle for the first 6 cycles and then, if the cancer is stable or improving, the interval between these imaging studies is lengthened to every 4 cycles. Patients whose tumors can be safely biopsied undergo this procedure before entering the study and 3 to 5 days after completing the first UCN-01 treatment. Biopsies requiring open surgery (e.g., in the chest or abdomen) are done only if absolutely necessary for medical care. Biopsy tissue, blood, and other fluids are analyzed for gene and protein studies related to lymphoma research.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Relapsed or refractory systemic Anaplastic Large Cell Lymphoma (ALCL).

Relapsed or refractory mature T-cell lymphoma to include peripheral T-cell lymphoma unspecified and the following "specified" mature T-cell lymphomas: 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.

All patients should have evaluable or measurable disease on entry to study.

Histology confirmed by Laboratory of Pathology, NCI.

Performance Status ECOG less than or equal to 2.

Age 7 years or older.

Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 50 ml/min for patients at least 18 years. Pediatric patients should have maximum serum creatinine by age as follows:

- Less than age 7 and less than or equal to age 10 may have a Maximum Serum Creatinine of 1.0 mg/dl

- Less than age10 and less than or equal to age 15 may have a Maximum Serum Creatinine of 1.2 mg/dl

- Age 15 years or older may have a Maximum Serum Creatinine of 1.5 mg/dl

Alternatively, pediatric patients should have a creatinine clearance of greater than 50 m1/min/1.73m(2).

Total bilirubin less than 1.5 x ULN (patients with elevation of total bilirubin consistent with Gilbert's disease are eligible providing they have a normal direct bilirubin); AST less than or equal to 2.5 x ULN; ANC greater than 500/mm(3); and platelet greater than or equal to 50,000/mm(3); unless hematological impairment due to organ involvement by lymphoma.

Provides signed informed consent.

Not pregnant or nursing. This drug has unknown effects in pregnancy and on young infants/children.

HIV negative.

Willing to use contraception and continue for at least 8 weeks following the last treatment.

No active CNS lymphoma.

Patients should not have received systemic cytotoxic chemotherapy within 3 weeks of study entry.

Have recovered from the toxic effects of prior therapy to a grade less than or equal to 1.

No history of diabetes mellitus requiring insulin treatment.

No symptomatic pulmonary disease.

No evidence of symptomatic cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, exertional angina pectoris, cardiac arrhythmia).

Patients may not be concurrently receiving any other investigational agents.

Not a candidate for potentially curative (i.e. transplant) treatment at the time of study entry or the patient has a window of opportunity to receive ucn-01 before a transplant. Patients are required to have considered a transplant. If, having done this, they refuse it, decide against it or decide to wait, they would be eligible for this study.

Special Instructions:

Currently Not Provided

Keywords:

Protein Kinase Inhibition

Soluble Tac

Gene Expression Profiling

ALK Expression

Apoptosis

Recruitment Keyword(s):

Lymphoma

Anaplastic Large Cell Lymphoma

ALCL

T-Cell Lymphoma

Condition(s):

Lymphoma, Large-Cell, Ki-1

Lymphoma, T-Cell

Investigational Drug(s):

UCN-01

Investigational Device(s):

None

Intervention(s):

Drug: UCN-01

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Stein H, et al. The expression of the Hodgkin's disease associated antigen Ki-1 in reactive and neoplastic lymphoid tissue: evidence that Reed-Sternberg cells and histiocytic malignancies are derived from activated lymphoid cells. Blood. 1985 Oct;66(4):848-58.

Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95.

Falini B, et al. ALK+ lymphoma: clinico-pathological findings and outcome. Blood. 1999 Apr 15;93(8):2697-706.

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