Clinical trial · Observational
Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol
NCT00003569CI-TRIAL-00009228completedClinicalTrials.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. Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Neurotoxicity | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| dimesna | Drug | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy * Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease * No potentially curable type of cancer (e.g., newly diagnosed testicular cancer) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 6 weeks Hematopoietic: * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin normal * SGOT and SGPT normal Renal: * Creatinine normal * Creatinine clearance at least 60 mL/min Cardiovascular: * No evidence of congestive heart failure * No uncontrolled moderate to severe hypertension * Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment Other: * No active infection * No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy * No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle * No severe medical problems unrelated to malignancy that would interfere with compliance in this study * Not pregnant * Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent colony stimulating factors except for febrile neutropenia * No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections * No concurrent immunotherapy Chemotherapy: * At least 6 weeks since prior nitrosoureas or mitomycin * At least 3 weeks since other prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to measurable disease Surgery: * At least 2 weeks since prior major surgery Other: * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.