Can a Two-Drug combo beat tough childhood cancers?
NCT ID NCT00407433
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining two chemotherapy drugs, gemcitabine and oxaliplatin, can shrink tumors in children and adolescents with certain solid cancers that have come back or not responded to standard treatment. The study includes patients with medulloblastoma, other central nervous system tumors, neuroblastoma, and osteosarcoma. Participants receive the drug combination for several cycles, and researchers measure how many achieve a complete or partial response, along with how long the benefit lasts and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine combined with oxaliplatin
- What this could lead to
- If effective, this combination could offer a new treatment option for children with hard-to-treat solid tumors that have not responded to standard therapies.
- What could go wrong
- This is a phase 2 trial, so the treatment may not work for all tumor types and could cause significant side effects. Results are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 20 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed malignant solid tumor (at diagnosis) * Relapsed or refractory tumors in which correct standard treatment approaches have failed * Measurable primary and/or metastatic disease: at least one bi-dimensionally measurable lesion. For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993). For patients with osteosarcoma, measurable lesions are lung metastases and osseous lesions with soft tissue tumor, in exclusion of completely calcified or necrosed lesion at study entry. A patient with an unique osseous lesion without soft tissue mass can be included in the study if the lesion is operable and thus accessible for histological response assessment. * No more than one salvage therapy for relapse * Age at inclusion: 6 months to ≤ 20 years * Lansky play score ≥ 70% or ECOG performance status ≤ 1 * Life expectancy ≥ 3 months * Adequate organ function: * Adequate hematological function: neutrophil count \>= 1.0 x 10\^9/L, platelet count \>= 100 x 10\^9/L; in case of bone marrow disease: \>= 75 x 10\^9/L; hemoglobin \>= 8 g/dL * Adequate renal function: creatinine \> 1.5 x ULN for age; If serum creatinine is \> 1.5 ULN of age, then creatinine clearance (or radioisotope GFR) must be \> 70 ml/min/1.73 m2 Adequate hepatic function: bilirubin \> 1.5 x ULN; AST and ALT \> 2.5 x ULN (AST, ALT ≤ 5 x ULN in case of liver metastases). * Wash out of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 4 weeks in case of prior radiotherapy. Patients must have recovered from the acute toxic effects of all prior therapy before enrollment into the study. * Able to comply with scheduled follow-up and with management of toxicity * All patients with reproductive potential must practice an effective method of birth control while on study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment. * Written informed consent from patient, parents or legal guardian Exclusion Criteria: * Concurrent administration of any other antitumor therapy. * Have previously completed or withdrawn from this study or any other study investigating gemcitabine or oxaliplatin. * Have a serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study * Pre-existing sensory or motor neuropathy \>Grade 2 (excluding neuropathy due to disease and/or surgery) * History of allergic reaction to platinum compounds * Are pregnant or breast feeding * Presence of symptomatic brain metastases in patients with solid non-central nervous system (CNS) tumors
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institut Gustave Roussy
Villejuif, 94800, France
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