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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; Chronic Lymphocytic Leukemia

Intervention: Deoxycoformycin (DCF) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Razelle Kurzrock, MD, Principal Investigator, Affiliation: MD Anderson

Summary

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

Clinical Details

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

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

Primary outcome: Number of Participants with Overall Response

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

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Public website for M. D. Anderson Cancer Center

Starting date: September 1994
Last updated: August 1, 2012

Page last updated: August 23, 2015

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