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

Overview

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

  • 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

Detailed Description

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

Interventions

  • 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

Primary 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

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Razelle Kurzrock, MD, Principal Investigator, MD Anderson

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