A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; Chronic Lymphocytic Leukemia
Intervention: Deoxycoformycin (DCF) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Razelle Kurzrock, MD, Principal Investigator, Affiliation: MD Anderson
Summary
The purpose of this study is to determine the side effects and antitumor response of
patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
Clinical Details
Official title: A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Participants with Overall Response
Detailed description:
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported
responses in lymphoid malignancies but larger studies are needed.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
M. D. Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Public website for M. D. Anderson Cancer Center
Starting date: September 1994
Last updated: August 1, 2012
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