506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Stopped early · Phase 2
Conditions studied: Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome
In brief
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma
Key facts
- Study ID
- NCT00005982
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2000-04-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- Large cell transformation of cutaneous T-cell lymphoma allowed
- No active CNS disease
- Performance status - Zubrod 0-2
- Absolute neutrophil count at least 1,000/mm\^3*
- Platelet count at least 100,000/mm\^3*
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 2.5 times ULN
- Creatinine clearance greater than 50 mL/min
- No history of symptomatic cardiac dysfunction
- No history of pericardial effusion
- HIV negative
- No grade 2 or greater sensory or motor neuropathy
- No history of seizures
- No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
- No medical, psychiatric, or social condition that would preclude study
- No other concurrent serious illness or active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior stem cell or bone marrow transplantation (BMT)
- No more than 1 prior immunotherapy regimen
- No more than 3 prior systemic regimens with denileukin diftitox
- At least 3 weeks since prior biologic therapy
- No concurrent BMT
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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