The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
Full Title of Study: “A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 29, 2006
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.
- Drug: Deoxycoformycin (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.
Arms, Groups and Cohorts
- Experimental: Deoxycoformycin (DCF)/Pentostatin
Clinical Trial Outcome Measures
- Number of Participants with Overall Response
- Time Frame: 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).
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- M.D. Anderson Cancer Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Razelle Kurzrock, MD, Principal Investigator, MD Anderson
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