Chronic Lymphocytic Leukemia, Cutaneous T-cell Lymphoma, Peripheral T-cell Lymphoma
Conditions
Keywords
Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor, T-cells
Brief summary
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
Detailed description
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.
Interventions
DRUGDeoxycoformycin (DCF)
Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologic proof of lymphoid malignancy with an expected complete response rate of less than 20 percent OR have failed at least one prior therapy. * No chemotherapy within 3 weeks of entry into study and must have recovered from acute toxic effects of prior therapy. * Life expectancy of at least 12 weeks. * Performance status equal to or less than Zubrod 2. * Signed informed consent. * Patients with measurable disease. * Age at least 16 years. * Adequate bone marrow function (unless involvement of bone marrow by lymphoma) defined as AGC greater than 1500 and platelet count greater than 100,000. * Adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than or equal to 4 times the upper limits of normal. * Adequate renal function defined as serum creatine less than or equal to 1.5 mg %.
Exclusion criteria
* No serious intercurrent illness. * Adequate contraception (if applicable). * NO patients with significant cardiac disease, i.e. New York Heart Association (NYHA) class III or IV. * NO experimental clinical trial within 3 weeks of study entry. * NO patients with active CNS disease. * Full recovery from any prior surgical treatment. * NO active active infections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Overall Response | Baseline and approximately every 3 weeks thereafter | Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR). |
Countries
United States
Outcome results
None listed