Primary Eligibility:
- 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
- Requires systemic therapy for at least 1 of the following conditions:
- Symptomatic disease
- High risk for organ dysfunction
- Active organ dysfunction
- Ineligible for, or refused potentially curative therapy (i.e., transplantation)
- ECOG performance status < 2
- Adequate hematologic, renal, and hepatic function
- HIV negative
- No pregnant or nursing females; all subjects must be willing to use contraception and continue for at least 8 weeks after last treatment
- At least 3 weeks since treatment with systemic cytotoxic chemotherapy
- At least 6 weeks since treatment with nitrosureas or mitomycin C
- No active CNS lymphoma
- Age 9 and over
- No history of diabetes mellitus requiring insulin treatment
- No symptomatic pulmonary or cardiac disease
- No concurrent use of other investigational agents
- Recovery from toxic effects of prior therapies
Treatment Plan:
- 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
- In the absence of disease progression or unacceptable toxicity, patients may continue to receive UCN-01 for 1 year beyond achieving maximum response or stable disease
- 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
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers
Reviewed: 1/30/09
Updated: 10/14/08
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