Status:
TERMINATED
UCN-01 (7-Hydroxystaurosporine) to Treat Relapsed T-Cell Lymphomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lymphoma, Large-Cell, Ki-1
Lymphoma, T-Cell
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Background: * UCN-01 (7-hydroxystaurosporine), a non-specific protein kinase C (PKC) inhibitor appears to have several mechanisms of action including protein kinase C (PKC) isoenzyme inhibition and c...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 5 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00082017
Start Date
April 5 2004
End Date
September 27 2011
Last Update
May 15 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892