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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038025
First received: May 24, 2002
Last updated: August 1, 2012
Last verified: August 2012

May 24, 2002
August 1, 2012
September 1994
August 2006   (final data collection date for primary outcome measure)
Number of Participants with Overall Response [ Time Frame: Baseline and approximately every 3 weeks thereafter ] [ Designated as safety issue: No ]
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).
Not Provided
Complete list of historical versions of study NCT00038025 on ClinicalTrials.gov Archive Site
Not Provided
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A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies

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

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

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Peripheral T-cell Lymphoma
  • Cutaneous T-cell Lymphoma
  • Chronic Lymphocytic Leukemia
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.
Other Names:
  • Nipent
  • Pentostatin
Experimental: Deoxycoformycin (DCF)/Pentostatin
Intervention: Drug: Deoxycoformycin (DCF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2006
August 2006   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038025
DM94-026
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Razelle Kurzrock, MD MD Anderson
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP