O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00003613 |
Recruitment Status
:
Terminated
First Posted
: January 27, 2003
Last Update Posted
: January 11, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Stage I Cutaneous T-cell Non-Hodgkin Lymphoma Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Drug: O6-benzylguanine Drug: carmustine Other: laboratory biomarker analysis | Phase 1 |
PRIMARY OBJECTIVES:
I. 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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma |
Study Start Date : | April 1999 |
Actual Primary Completion Date : | May 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment (O6-benzylguanine, 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.
|
Drug: O6-benzylguanine
Given IV
Other Name: BG
Drug: carmustine
Given topically
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003613
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 |
Principal Investigator: | Kevin Cooper | Case Western Reserve University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003613 History of Changes |
Other Study ID Numbers: |
NCI-2012-03119 CWRU 6496 U01CA062502 ( U.S. NIH Grant/Contract ) |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | January 11, 2013 |
Last Verified: | January 2013 |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Carmustine O(6)-benzylguanine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |