Recurrent Cutaneous T-cell Non-Hodgkin LymphomaPhase 1NCT00003613
O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma
A Phase 1 study testing O6-benzylguanine, carmustine and laboratory biomarker analysis in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- What is being tested?
- O6-benzylguanine, carmustine and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to May 2006
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed CTCL, stages IA-IIA
- Performance status ECOG grade 0, 1, or 2
- Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emoliation for at least 4 weeks
- Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects
- WBC > 4,000/ul
- ANC > 2,000/ul
Show all 16Show fewer
- Platelets > 100,000/ul
- Bilirubin < 1.5 mg/dL
- SGOT within normal range
- Prothrombin time within normal range
- Creatinine =< 1.5 mg/dL or creatinine clearance >= 70 ml/min
- Calcium and electrolytes normal
- Glucose-controlled (diet and insulin) diabetes is permitted
- DLCO > 80% normal with the exception of patients who demonstrate clinically normal lung function based on history, physical examination, and chest x-ray as interpreted by the principal investigator
- Only those patients with biopsiable tumor and willing to undergo several biopsies will be eligible
- Must have failed 1 conventional treatment other than topical corticosteroids; this includes UVB, PUVA, topical mechlorethamine, electron beam, photopheresis, chemotherapy and immuno-modulatory agents such as cytokines
Who cannot join
- Patients with a prior treatment with a nitrosourea
- Patients with known central nervous system involvement or primary CNS malignancies will be ineligible
- Patients with performance status ECOG grade 3 or 4
- Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception, because of potential toxicity to the fetus or infant
- Patients with active infection
- Patients with pulmonary disease as determined by history, physical examination, chest X-ray or pulse oximetry
- CTCL patients with stage IIB-IVB disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma
This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the toxicity of low dose BCNU plus O6BG.
OUTLINE: This is a dose-escalation study of carmustine.
Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for 6 weeks.
- Conditions
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Being tested
- O6-benzylguanine, carmustine, laboratory biomarker analysis
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O6-benzylguanineDrug
Also called BG
Given IV
carmustineDrug
Also called BCNU, BiCNU, bis-chloronitrosourea
Given topically
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (O6-benzylguanine, carmustine) | Experimental | Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: O6-benzylguanine; Drug: carmustine; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples
Point and interval estimates of response using the binomial distribution will be obtained using data from patients with measurable or evaluable disease. If responses occur, then the mean and median duration of response will be determined. Statistical significance will be determined using the t test for analysis of continuous data.
Measured: Baseline to 6 weeks
MTD of carmustine estimated as the dose level which is one level below where >= 2 DLT are observed
Toxicities will be recorded and tabulated. Additional point and interval estimates for the MTD will be obtained using the methods of logistic regression of the proportion of patients experiencing a dose-limiting toxicity of grade >= 2 and by conventional regression of the mean dose-limiting toxicities on dose level.
Measured: 6 weeks
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 1999
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin Cooper, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003613
- Sponsor's protocol ID
- NCI-2012-03119
- Other IDs
- CWRU 6496, U01CA062502
- Status last verified
- Jan 2013
- First submitted
- 1 Nov 1999
- Last updated
- 11 Jan 2013
- Results posted
- No
Publications
Apisarnthanarax N, Wood GS, Stevens SR, Carlson S, Chan DV, Liu L, Szabo SK, Fu P, Gilliam AC, Gerson SL, Remick SC, Cooper KD. Phase I clinical trial of O6-benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, mycosis fungoides type. Arch Dermatol. 2012 May;148(5):613-20. doi: 10.1001/archdermatol.2011.2797.
PubMed 22250189
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00003613
- Acronym / sponsor ID
- NCI-2012-03119
- Conditions
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 1999
- Primary completion
- May 2006 (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.
This phase I trial is studying the side effects and best dose of carmustine given together with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells
Detailed description
PRIMARY OBJECTIVES:
- To determine the kinetics of AGT depletion in CTCL skin lesions. II. To determine the toxicity of low dose BCNU plus O6BG.
OUTLINE: This is a dose-escalation study of carmustine.
Patients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carmustine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (O6-benzylguanine, carmustine) | Experimental | Drug: O6-benzylguanine, Drug: carmustine, Other: laboratory biomarker analysisPatients receive O6-benzylguanine IV over 1 hour followed by topical carmustine once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed CTCL, stages IA-IIA
- Performance status ECOG grade 0, 1, or 2
- Patients must have recovered from toxicity of prior treatment and have received no CTCL therapy other than emoliation for at least 4 weeks
- Patients must have signed a consent form indicating the investigational nature of the treatment and its potential side effects
- WBC > 4,000/ul
Key exclusion criteria (7 listed)
- Patients with a prior treatment with a nitrosourea
- Patients with known central nervous system involvement or primary CNS malignancies will be ineligible
- Patients with performance status ECOG grade 3 or 4
- Pregnant women, women who are breast feeding infants, or women with reproductive potential not practicing adequate contraception, because of potential toxicity to the fetus or infant
- Patients with active infection
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 |
|---|---|---|
| O6-benzylguanineAlso: BGGiven IV | Drug | Treatment (O6-benzylguanine, carmustine) |
| carmustineAlso: BCNU, BiCNU, bis-chloronitrosoureaGiven topically | Drug | Treatment (O6-benzylguanine, carmustine) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (O6-benzylguanine, carmustine) |
Primary outcome
Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples
Time frame: Baseline to 6 weeks
Point and interval estimates of response using the binomial distribution will be obtained using data from patients with measurable or evaluable disease. If responses occur, then the mean and median duration of response will be determined. Statistical significance will be determined using the t test for analysis of continuous data.
MTD of carmustine estimated as the dose level which is one level below where >= 2 DLT are observed
Time frame: 6 weeks
Toxicities will be recorded and tabulated. Additional point and interval estimates for the MTD will be obtained using the methods of logistic regression of the proportion of patients experiencing a dose-limiting toxicity of grade >= 2 and by conventional regression of the mean dose-limiting toxicities on dose level.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2013.
- Derived from this study: PubMed 22250189Apisarnthanarax N, Wood GS, Stevens SR, Carlson S, Chan DV, Liu L, Szabo SK, Fu P, Gilliam AC, Gerson SL, Remick SC, Cooper KD. Phase I clinical trial of O6-benzylguanine and topical carmustine in the treatment of cutaneous T-cell lymphoma, mycosis fungoides type. Arch Dermatol. 2012 May;148(5):613-20. doi: 10.1001/archdermatol.2011.2797.
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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.
Kevin Cooper principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing O6-benzylguanine, carmustine and laboratory biomarker analysis in people with Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma and Stage I Cutaneous T-cell Non-Hodgkin Lymphoma, 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 16 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: stopped early, as of the sponsor's last update on 11 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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?
Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples (time frame: Baseline to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003613, which also lists 1 linked publication.
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 11 Jan 2013.