A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies

Study Overview
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Brief Summary
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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
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Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.

Official Title
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A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies

Conditions
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Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, Chronic Lymphocytic Leukemia

Intervention / Treatment
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* Drug: Deoxycoformycin (DCF)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deoxycoformycin (DCF)/Pentostatin<br> | Drug: Deoxycoformycin (DCF)<br>* Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.<br>* Other names: Pentostatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Overall Response | Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR). | Baseline and approximately every 3 weeks thereafter | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor, T-cells