Clinical trial · Interventional
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer
NCT00025129CI-TRIAL-00011396completedPhase 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 cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laromustine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed advanced and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists * Measurable or evaluable metastatic disease * No other hematologic malignancy * No large pleural, pericardial, or peritoneal effusions * No requirement for immediate palliative treatment, including surgery * No symptomatic brain metastases or metastases with substantial edema * Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hematocrit at least 30% (transfusion allowed) * No active uncontrolled bleeding Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) * Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present) * PT and aPTT no greater than 1.5 times ULN * Albumin at least 2.5 g/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * Ejection fraction at least 45% * No active heart disease * No myocardial infarction within the past 3 months * No symptomatic coronary artery disease * No arrhythmias requiring medication * No uncontrolled congestive heart failure Pulmonary: * DLCO and FEV\_1 at least 60% of predicted * No dyspnea with minimal to moderate exertion Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * HIV negative * No active infection * Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1 * No bleeding diathesis (e.g., active peptic ulcer disease) PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic agents and recovered * At least 6 months since prior high-dose chemotherapy regimen with stem cell support Chemotherapy: * See Biologic therapy * At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: * At least 2 weeks since prior hormonal therapy and recovered Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * At least 2 weeks since prior surgery and recovered Other: * No other concurrent standard therapy for cancer * No other concurrent investigational agents * No concurrent disulfiram (Antabuse)
References
Publications (0)
Data not yet available
No reference posted for this study.