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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038025
• Other study ID #: DM94-026
• Status: Completed
• Phase: Phase 2
• Start date: September 6, 1994
• Est. completion date: November 29, 2006

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 29, 2006
• Est. primary completion date: November 29, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Cutaneous T-cell Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
United States	M. D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Public website for M. D. Anderson Cancer Center