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

This study has been completed.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038025
  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 Intervention Phase
Peripheral T-Cell Lymphoma
Cutaneous T-Cell Lymphoma
Chronic Lymphocytic Leukemia
Drug: Deoxycoformycin (DCF)/Pentostatin
Phase II

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

Drug Information available for:   Adenosine    Pentostatin   

U.S. FDA Resources

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 as provided by M.D. Anderson Cancer Center:

Estimated Enrollment:   100
Study Start Date:   September 1994
Study Completion Date:   March 2007

Detailed Description:

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038025

Locations
United States, Texas
M. D. Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center

Investigators
Principal Investigator:     Razelle Kurzrock, MD     MD Anderson    
  More Information


Public website for M. D. Anderson Cancer Center  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   DM94-026
First Received:   May 24, 2002
Last Updated:   March 19, 2007
ClinicalTrials.gov Identifier:   NCT00038025
Health Authority:   United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Mycosis Fungoides  
Lymphoma  
Chronic lymphocytic leukemia  
Deoxycoformycin  
Pentostatin  
All other lymphomas
Nucleoside analogue
Adenosine deaminase inhibitor
T-cells

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Pentostatin
Sezary syndrome
Leukemia, Lymphoid
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Sezary Syndrome
Mycosis Fungoides
Lymphoma, T-Cell, Peripheral
Mycoses
Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Adenosine
Lymphoma
Peripheral T-cell lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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