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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Completed
Phase 2

Conditions

Cutaneous T-cell Lymphoma
Chronic Lymphocytic Leukemia
Peripheral T-cell Lymphoma

Treatments

Drug: Deoxycoformycin (DCF)

Study type

Interventional

Funder types

Other

Identifiers

NCT00038025
DM94-026

Details and patient eligibility

About

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

Full description

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

Enrollment

60 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Deoxycoformycin (DCF)/Pentostatin
Experimental group
Treatment:
Drug: Deoxycoformycin (DCF)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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