Recurrent Cutaneous T-cell Non-Hodgkin LymphomaPhase 2NCT00005982
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
A Phase 2 study testing nelarabine and pharmacological study in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides/Sezary Syndrome, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome
- What is being tested?
- nelarabine and pharmacological study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Jul 2004
- 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
- Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- Large cell transformation of cutaneous T-cell lymphoma allowed
- No active CNS disease
- Performance status - Zubrod 0-2
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 100,000/mm^3*
Show all 41Show fewer
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGPT no greater than 2.5 times ULN
- Creatinine clearance greater than 50 mL/min
- No history of symptomatic cardiac dysfunction
- No history of pericardial effusion
- HIV negative
- No grade 2 or greater sensory or motor neuropathy
- No history of seizures
- No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
- No medical, psychiatric, or social condition that would preclude study
- No other concurrent serious illness or active infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior stem cell or bone marrow transplantation (BMT)
- No more than 1 prior immunotherapy regimen
- No more than 3 prior systemic regimens with denileukin diftitox
- At least 3 weeks since prior biologic therapy
- No concurrent BMT
- No prior 506U78
- No more than 3 prior systemic chemotherapy regimens comprising any of the following:
- Oral methotrexate
- Topical mechlorethamine
- At least 3 weeks since prior chemotherapy
- No other concurrent chemotherapy
- At least 3 weeks since prior anticancer endocrine therapy
- No concurrent topical or systemic steroids
- At least 3 weeks since prior radiotherapy
- No more than 3 prior systemic regimens comprising any of the following:
- Total skin electron beam therapy
- Spot radiotherapy
- No more than 3 prior systemic regimens comprising any of the following:
- Oral retinoids
- Ultraviolet therapy (PUVA)
- At least 3 weeks since prior anticancer therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.
- Conditions
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome
- Being tested
- nelarabine, pharmacological study
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nelarabineDrug
Also called 506U78, Arranon, GW506U78
Given IV
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nelarabine) | Experimental | Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: nelarabine; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (RR) defined as CR + PR rates
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2000
- Primary completionJul 2004
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Cutaneous T-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andre Goy, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005982
- Sponsor's protocol ID
- NCI-2012-02344
- Other IDs
- ID99-213, CDR0000067970
- Status last verified
- Jan 2013
- First submitted
- 5 Jul 2000
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00005982
- Acronym / sponsor ID
- NCI-2012-02344
- Conditions
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2000
- Primary completion
- Jul 2004 (actual)
- First posted
- 27 Jan 2003 (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.
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma
Detailed description
PRIMARY OBJECTIVES:
- Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
II. Determine the toxicity of this drug in these patients. III. Study the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nelarabine) | Experimental | Drug: nelarabine, Other: pharmacological studyPatients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (41 listed)
- Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- No active CNS disease
- Performance status - Zubrod 0-2
- Absolute neutrophil count at least 1,000/mm^3*
- Platelet count at least 100,000/mm^3*
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nelarabineAlso: 506U78, Arranon, GW506U78Given IV | Drug | Treatment (nelarabine) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (nelarabine) |
Primary outcome
Response rate (RR) defined as CR + PR rates
Time frame: Up to 4 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
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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.
Andre Goy principal investigator
M.D. Anderson Cancer Center
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 nelarabine and pharmacological study in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides/Sezary Syndrome, run by National Cancer Institute (NCI) 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 41 inclusion and 0 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: stopped early, as of the sponsor's last update on 23 Jan 2013. 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 was stopped early (reason given: Administratively complete.). Results are not available in the source record.
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?
Response rate (RR) defined as CR + PR rates (time frame: Up to 4 years). 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 23 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.