Clinical trial · Interventional
Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
A PHASE I STUDY OF IRINOTECAN (CPT-11) WITH PHARMACOKINETIC MODULATION BY CYCLOSPORINE A AND PHENOBARBITAL
NCT00002759CI-TRIAL-00009303completedPhase 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)
Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in treating patients who have solid tumors or lymphoma that is refractory to standard therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Cyclosporine and phenobarbital may enhance the effectiveness of irinotecan.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| phenobarbital | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- See detailed description.
- interventionNames
- Drug: cyclosporine
- Drug: irinotecan hydrochloride
- Drug: phenobarbital
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Malignant solid tumor or lymphoma refractory to standard therapy or for which no therapy of proven benefit exists * No leukemia * Measurable or evaluable disease PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: Karnofsky 70-100% * Life expectancy: At least 3 months * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9 g/dL * Bilirubin no greater than 1.5 mg/dL * AST/ALT less than twice normal (unless due to disease) * PT and PTT normal * Creatinine no greater than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No history of congestive heart failure requiring medical therapy * No clinically significant or life threatening cardiac arrhythmia * No history of significant pulmonary disease or lymphangitic lung disease * No hypersensitivity to cyclosporine or cremophore * No history of manifest or latent porphyria or hypersensitivity to barbiturates (for parts of study using phenobarbital) * No history of inflammatory bowel disease requiring therapy * No chronic diarrhea syndrome or paralytic ileus * No medical or psychiatric condition that precludes informed consent * Not pregnant * Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior biologic therapy * At least 2 weeks since prior colony stimulating factors * At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or mitomycin) * No prior bleomycin or irinotecan * At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow * Minimum time interval between prior therapy and eligibility shortened by 2 weeks when phenobarbital is administered * Concurrent use of medications that affect the central nervous or cardiovascular systems (e.g., anticonvulsants, calcium channel blockers, oral contraceptives) must be approved by the Principal Investigator
References
Publications (0)
Data not yet available
No reference posted for this study.