Clinical trial · Interventional
O(6)-Benzylguanine and Carmustine in Treating Patients With Solid Tumors
Phase I Trial of O6 Benzylguanine and BCNU; A Biochemical Modulation Trial Based Upon Depletion of O6 Alkylguanine DNA Alkyltransferase Directed DNA Repair
NCT00002604CI-TRIAL-00003651completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine and carmustine in treating patients who have solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| chemosensitization/potentiation therapy | Drug | — | UNRESOLVED |
| O6-benzylguanine | Drug | O6-Benzylguanine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- dose escalation study of 06-benzylguanine (BG) and carmustine (BCNU)
- timeFrame
- Courses (each course is 3 weeks) repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of BG until the biochemical modulation dose l (BMDl) is determined.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor for which no standard treatment exists (including surgery, radiotherapy, or systemic agents) No primary CNS malignancy No CNS metastases Only disease that can be sequentially biopsied is eligible for determination of the biochemical modulating dose that decreases AGT in tumor tissue PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Hematopoietic: WBC greater than 4,000/mm3 Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Prothrombin time less than upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Calcium normal Electrolytes normal Other: Diabetes controlled by diet or insulin allowed Not pregnant Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since mitomycin) and recovered No prior nitrosoureas Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.