Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
16 Years
N/A
Both
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome
Trial Information
Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
PRIMARY OBJECTIVES:
I. Determine the response rate, failure-free survival, and progression-free survival of
patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics
of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28
days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.
Inclusion Criteria:
- 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
- No prior 506U78
- No more than 3 prior systemic chemotherapy regimens comprising any of the following:
- Oral methotrexate
- Topical mechlorethamine
- At least 3 weeks since prior chemotherapy
- No other concurrent chemotherapy
- At least 3 weeks since prior anticancer endocrine therapy
- No concurrent topical or systemic steroids
- At least 3 weeks since prior radiotherapy
- No more than 3 prior systemic regimens comprising any of the following:
- Total skin electron beam therapy
- Spot radiotherapy
- No more than 3 prior systemic regimens comprising any of the following:
- Oral retinoids
- Ultraviolet therapy (PUVA)
- At least 3 weeks since prior anticancer therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate (RR) defined as CR + PR rates
Outcome Time Frame:
Up to 4 years
Safety Issue:
No
Principal Investigator
Andre Goy
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02344
NCT ID:
NCT00005982
Start Date:
April 2000
Completion Date:
Related Keywords:
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Lymphoma
- Lymphoma, Non-Hodgkin
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| M D Anderson Cancer Center | Houston, Texas 77030 |
