MedulloblastomaPhase 2NCT00407433
Clinical Studies of Gemcitabine-Oxaliplatin
A Phase 2 study testing Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) in people with Medulloblastoma and Central Nervous System Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors. Read more about this study
- Who is it for?
- Ages 6 months to 20 years
- Conditions the study is for
- Medulloblastoma, Central Nervous System Tumors, Neuroblastoma
- What is being tested?
- Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors
These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.
- Being tested
- Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)
- Keywords
- Gemcitabine, Oxaliplatine, Paediatric solid tumors, Other CNS tumors, Other miscellaneous solid non-CNS tumours
- Medical subject headings
- Medulloblastoma, Central Nervous System Neoplasms, Neuroblastoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).
Secondary outcomes (2)
The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.
Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MedulloblastomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Geoerger, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407433
- Sponsor's protocol ID
- IGR 1205
- Other IDs
- ITCC-004-GEMOX
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2006
- Last updated
- 17 Aug 2026
- Results posted
- No
Publications
Geoerger B, Chisholm J, Le Deley MC, Gentet JC, Zwaan CM, Dias N, Jaspan T, Mc Hugh K, Couanet D, Hain S, Devos A, Riccardi R, Cesare C, Boos J, Frappaz D, Leblond P, Aerts I, Vassal G; European Consortium Innovative Therapies for Children with Cancer (ITCC). Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study. Eur J Cancer. 2011 Jan;47(2):230-8. doi: 10.1016/j.ejca.2010.09.015. Epub 2010 Oct 11.
PubMed 20943374
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single-Arm Studies of Gemcitabine in Combination With Oxaliplatin Refractory and Relapsed Pediatric Solid Tumors
- ClinicalTrials.gov ID
- NCT00407433
- Acronym / sponsor ID
- IGR 1205
- Keywords
- Gemcitabine, Oxaliplatine, Paediatric solid tumors, Other CNS tumors, Other miscellaneous solid non-CNS tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
These are Phase 2 single-arm studies of gemcitabine in combination with oxaliplatin in refractory or relapsing pediatric solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) | Drug | – |
Primary outcome
The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).
2 secondary outcomes
The secondary efficacy variables are the duration of response, the time to treatment failure, the time to progressive disease and the overall survival.
Clinical and laboratory toxicities/symptomatology will be graded according to NCI-Common toxicity criteria AE v3.0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 20943374Geoerger B, Chisholm J, Le Deley MC, Gentet JC, Zwaan CM, Dias N, Jaspan T, Mc Hugh K, Couanet D, Hain S, Devos A, Riccardi R, Cesare C, Boos J, Frappaz D, Leblond P, Aerts I, Vassal G; European Consortium Innovative Therapies for Children with Cancer (ITCC). Phase II study of gemcitabine combined with oxaliplatin in relapsed or refractory paediatric solid malignancies: An innovative therapy for children with Cancer European Consortium Study. Eur J Cancer. 2011 Jan;47(2):230-8. doi: 10.1016/j.ejca.2010.09.015. Epub 2010 Oct 11.
Related trials for Medulloblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingPhase 2
Digoxin Medulloblastoma Study
Medulloblastoma, Medulloblastoma, Non-WNT/Non-SHH
RecruitingPhase 1
Adoptive T Cell Therapy, DC Vaccines, and Hematopoietic Stem Cells Combined With Immune checkPOINT Blockade in Patients With Medulloblastoma
Recurrent Group 3 Medulloblastoma, Recurrent Group 4 (Non-SHH/Non-WNT) Medulloblastoma
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
RecruitingPhase 1
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Ependymoma, Medulloblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Geoerger, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine (Gemzar®), Oxaliplatin (Eloxatin®) in people with Medulloblastoma and Central Nervous System Tumors, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for efficacy is the percentage of patients achieving complete or partial response according to WHO guidelines, after having received 4 cycles of gemcitabine-oxaliplatin (8 weeks).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00407433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.