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

Phase 2
16 Years
Not Enrolling
Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Overall Response

Outcome Description:

Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).

Outcome Time Frame:

Baseline and approximately every 3 weeks thereafter

Safety Issue:


Principal Investigator

Razelle Kurzrock, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson


United States: Food and Drug Administration

Study ID:




Start Date:

September 1994

Completion Date:

November 2006

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Cutaneous T-cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • Mycosis Fungoides
  • Lymphoma
  • Chronic lymphocytic leukemia
  • Deoxycoformycin
  • Pentostatin
  • All other lymphomas
  • Nucleoside analogue
  • Adenosine deaminase inhibitor
  • T-cells
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral



M. D. Anderson Cancer Center Houston, Texas  77030