Clinical trial · Interventional
O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma
Phase I Trial of O6 Benzylguanine and BCNU in Cutaneous T-cell Lymphoma
NCT00003613CI-TRIAL-00008868terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Cutaneous T-cell Non-Hodgkin Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (O6-benzylguanine, carmustine)
- description
- 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.
- interventionNames
- Drug: O6-benzylguanine
- Drug: carmustine
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Percent decrease of AGT in CTCL skin lesions, obtained from tissue samples
- timeFrame
- Baseline to 6 weeks
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDApisarnthanarax 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. PMID 22250189