Clinical trial · Interventional
VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors
Phase I Study Of Cloretazine (VNP40101M) In Children With Recurrent, Progressive Or Refractory Primary Brain Tumors
- 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, such as VNP40101M, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase I trial is studying the side effects and best dose of VNP40101M in treating young patients with recurrent, progressive, or refractory primary brain 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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laromustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Estimate the maximum tolerated dose
- timeFrame
- First 6 weeks of therapy
- measure
- Number of participants with dose limiting toxicities
- timeFrame
- First 6 weeks of therapy
Secondary outcomes (2)
- measure
- Pharmacokinetics
- timeFrame
- Day 1 of therapy
- description
- Plasma samples for pharmacokinetic studies will be collected with the first dose of the study drug pre-infusion, and 5, 15, and 30 minutes, 1 hour, 2 hours, and 4 hours after the end of infusion. VNP40101M plasma concentration-time data will be modeled and the individual pharmacokinetic pararmeters volume of the central compartment, elimination rate constant, and half-life will be estimated.
- measure
- Tumor response to VNP40101M
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed\* primary brain tumor, including benign brain tumors (e.g., low-grade glioma) * Recurrent or progressive disease OR refractory to standard therapy NOTE: \*Patients with intrinsic brain stem or diffuse optic pathway tumors do not require histological confirmation, but must have clinical and/or radiographic evidence of disease progression * No bone marrow disease PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Karnofsky 50-100% (for patients \> 16 years of age) OR * Lansky 50-100% (for patients ≤ 16 years of age) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count ≥ 100,000/mm\^3\* * Hemoglobin ≥ 8 g/dL\* NOTE: \*Unsupported Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT and AST ≤ 2.5 times ULN * No overt hepatic disease Renal * BUN \< 25 mg/dL * Creatinine ≤ 1.5 times ULN for age OR * Glomerular filtration rate \> 70 mL/min * No overt renal disease Cardiovascular * Shortening fraction ≥ 30% by echocardiogram OR * Ejection fraction ≥ 50% by gated radionucleotide study * No clinically significant cardiac arrhythmia by EKG * No overt cardiac disease Pulmonary * DLCO ≥ 60% of predicted * Chest X-ray normal (defined as absence of pulmonary infiltrates, pneumonitis, pleural effusion, pulmonary hemorrhage, or fibrosis) AND a resting pulse oximetry reading of \> 94% in room air (for patients who cannot perform the DLCO) * No overt pulmonary disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Neurologic deficits allowed provided there has been no deficit progression for ≥ 1 week before study entry * No uncontrolled infection * No known hypersensitivity to polyethylene glycol PRIOR CONCURRENT THERAPY: Biologic therapy * At least 6 months since prior allogeneic bone marrow or stem cell transplantation * At least 3 months since prior autologous bone marrow or stem cell transplantation * More than 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa) * At least 3 weeks since prior myelosuppressive anticancer biologic therapy * No concurrent routine colony-stimulating factors Chemotherapy * At least 3 weeks since prior myelosuppressive anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy * Concurrent corticosteroids allowed provided dose is stable or decreasing for ≥ 1 week before study entry Radiotherapy * At least 3 months since prior craniospinal irradiation ≥ 18 Gy * At least 2 weeks since prior focal irradiation to the primary tumor and/or symptomatic metastatic sites Surgery * Not specified Other * At least 7 days since prior nonmyelosuppressive anticancer therapy * At least 7 days since prior investigational agents * Concurrent enzyme-inducing anticonvulsant drugs allowed * No other concurrent anticancer or experimental agents or therapies
References
Publications (1)
- RESULTGururangan S, Turner CD, Stewart CF, O'Shaughnessy M, Kocak M, Poussaint TY, Phillips PC, Goldman S, Packer R, Pollack IF, Blaney SM, Karsten V, Gerson SL, Boyett JM, Friedman HS, Kun LE. Phase I trial of VNP40101M (Cloretazine) in children with recurrent brain tumors: a pediatric brain tumor consortium study. Clin Cancer Res. 2008 Feb 15;14(4):1124-30. doi: 10.1158/1078-0432.CCR-07-4242. PMID 18281546