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


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Pentostatin

Nipent


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

This study is currently recruiting patients.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center

Purpose

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

Condition Treatment or Intervention Phase
Peripheral T-Cell Lymphoma
Cutaneous T-Cell Lymphoma
Chronic Lymphocytic Leukemia
 Drug: Deoxycoformycin (DCF)/Pentostatin
Phase II

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  100

Study start: September 1994

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

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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 %.
  • No serious intercurrent illness.
  • Adequate contraception (if applicable).
  • NO patients with significant cardiac disease, i.e. 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.

Location and Contact Information


Texas
      M. D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Susan R Pilat, RN, BSN  713-745-3296    spilat@mdanderson.org 
Razelle Kurzrock, MD  713-794-1226    rkurzroc@mdanderson.org 
Razelle Kurzrock, MD,  Principal Investigator

More Information

Public website for M. D. Anderson Cancer Center

Study ID Numbers:  DM94-026
Record last reviewed:  January 2005
Last Updated:  January 31, 2005
Record first received:  May 24, 2002
ClinicalTrials.gov Identifier:  NCT00038025
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 6, 2008



Page Updated: June 1, 2005
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