Clinical trial NCT00082017 (phase 2, status: terminated)
Conditions: lymphoma, large-cell, ki-1, lymphoma, t-cell
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: ucn-01 (7-hydroxystaurosporine)
SMILES: [H][C@]1(O)N=C(O)C2=C3C4=CC=CC=C4N4C3=C3N(C5=CC=CC=C5C3=C12)[C@@]1(C)O[C@]4([H])C[C@@]([H])(NC)[C@@]1([H])OC
Reason stopped: 
    ind was withdrawn by ctep due to low accrual and cost of maintaining the ind.
  
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 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.