Clinical trial · Interventional
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
A Phase I Trial of VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer
NCT00049699CI-TRIAL-00011417completedPhase 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 or metastatic cancer.
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 or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists * Measurable or evaluable disease * Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance 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 bleeding diathesis Hepatic * PT and PTT no greater than 1.5 times the upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN * ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) * Albumin at least 2.5 gm/dL Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * At least 3 months since prior myocardial infarction * No symptomatic coronary artery disease * No arrhythmias requiring medication * No uncontrolled congestive heart failure Pulmonary * No dyspnea on minimal or moderate exertion * DLCO and FEV1 at least 60% predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled active bleeding (e.g., active peptic ulcer disease) * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Chemotherapy * More than 6 months since prior high-dose chemotherapy with stem cell support * More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) * Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Endocrine therapy * At least 2 weeks since prior hormonal therapy Radiotherapy * Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Surgery * At least 2 weeks since prior surgery Other * No other concurrent standard or investigational treatment for cancer * No concurrent disulfiram
References
Publications (0)
Data not yet available
No reference posted for this study.