Peripheral T-cell LymphomaPhase 2NCT00038025
A Study Of Deoxycoformycin(DCF)/Pentostatin In Lymphoid Malignancies
A Phase 2 study testing Deoxycoformycin (DCF) in people with Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- Deoxycoformycin (DCF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 1994to 29 Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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 %.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
Read the detailed description
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.
- Being tested
- Deoxycoformycin (DCF)
- Keywords
- Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor, T-cells
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous, Leukemia, Lymphocytic, Chronic, B-Cell, Mycosis Fungoides, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deoxycoformycin (DCF)Drug
Also called Nipent, Pentostatin
Patients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Deoxycoformycin (DCF)/Pentostatin | Experimental | Not described Receives: Drug: Deoxycoformycin (DCF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Overall Response
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).
Measured: Baseline and approximately every 3 weeks thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2002 (estimated)
- Study start6 Sep 1994
- Primary completion29 Nov 2006
- Study completion29 Nov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Razelle Kurzrock, MD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038025
- Sponsor's protocol ID
- DM94-026
- Status last verified
- Nov 2018
- First submitted
- 24 May 2002
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Deoxycoformycin (DCF) in Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00038025
- Acronym / sponsor ID
- DM94-026
- Keywords
- Mycosis Fungoides, Lymphoma, Chronic lymphocytic leukemia, Deoxycoformycin, Pentostatin, All other lymphomas, Nucleoside analogue, Adenosine deaminase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 6 Sep 1994 (actual)
- Primary completion
- 29 Nov 2006 (actual)
- Study completion
- 29 Nov 2006 (actual)
- First posted
- 27 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the side effects and antitumor response of patients with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin.
Detailed description
Deoxycoformycin(DCF)/Pentostatin is a T-cell cytotoxic drug with previously reported responses in lymphoid malignancies but larger studies are needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deoxycoformycin (DCF)/Pentostatin | Experimental | Drug: Deoxycoformycin (DCF) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deoxycoformycin (DCF)Also: Nipent, PentostatinPatients received Deoxycoformycin (DCF)/Pentostatin administered by intravenous bolus daily over a consecutive 3-day period. This course was repeated at 3-week intervals. | Drug | Deoxycoformycin (DCF)/Pentostatin |
Primary outcome
Number of Participants with Overall Response
Time frame: Baseline and approximately every 3 weeks thereafter
Overall responses (OR) of participants with lymphoid malignancies to Deoxycoformycin (DCF)/Pentostatin defined as Complete Response (CR) and Partial Response (PR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Public website for M. D. Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Razelle Kurzrock, MD principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deoxycoformycin (DCF) in people with Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Overall Response (time frame: Baseline and approximately every 3 weeks thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.