UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas

• Status: Terminated
• Trial end date: 2011-09-27
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the effects of an experimental drug called UCN-01 (7-hydroxystaurosporine) 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 computed tomography (CT) scans of the chest, abdomen and pelvis. Additional tests may be done if clinically indicated, such as positron emission tomography (PET) scans, bone marrow aspirations and biopsies, lumbar punctures (spinal taps) and CT's or magnetic resonance imaging (MRI) scans if there is evidence of central nervous system disease.

Participants are given UCN-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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Staurosporine

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 natural killer (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, National Cancer Institute (NCI).

Performance Status Eastern Cooperative Oncology Group (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 upper limit of normal (ULN) (patients with elevation of total bilirubin consistent with Gilbert's disease are eligible providing they have a normal direct bilirubin);

aspartate aminotransferase (AST) less than or equal to 2.5 x ULN;

absolute neutrophil count (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.

Human immunodeficiency virus (HIV) negative.

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

No active central nervous system (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.