GliomasPhase 2HGG-CilMetroNCT01517776
Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents
A Phase 2 study testing Cilengitide and Temozolomide in people with Gliomas, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate the efficacy of a combined treatment with cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS) after diagnosis of relapse or tumour progression in children and adolescents with relapsed or refractory high-grade malignant glioma… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Gliomas
- What is being tested?
- Cilengitide and Temozolomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Apr 2014
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of high-grade malignant glioma confirmed by central neuropathological review (last MRI diagnosis not older than 4 weeks) - including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (analogous to WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV) - or diagnosis of diffuse intrinsic pontine glioma confirmed by central neuroradiological review - refractory to standard treatment, or relapsed or progressive after first-line therapy.
- Patient aged 3 years and older but under 18 years at time of relapse diagnosis
- Written informed consent of the patient (mandatory from 15 years of age) or the parents (mandatory till 18 years of age).
Who cannot join
- Known hypersensitivity or contraindication to any study drugs
- Other (simultaneous) malignancies
- Pregnancy and / or lactation
- Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
- Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- Severe concomitant diseases (e.g. immune deficiency syndrome) or HIV infection
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- Severe psychological disease or neurological damage without possibility to communicate
- Clinical signs of intracranial pressure
- Intracerebral hemorrhage or history of intracerebral hemorrhage
- Requirements for laboratory test results not older than 2 weeks before patient´s inclusion:
- Platelets < 100 000/µl (< 100 Gpt/l) PT, INR and PTT above normal range Absulute neutrophil count ≤ 1 500/µl (< 1,5 Gpt/l) Hemoglobin < 10g/dl (< 6,4 mmol/L) Serum creatinine ≥ 1,5 x upper limit of normal range or creatinine clearance rate ≤ 60 ml/min/m2 (corrected for body surface area) Total bilirubin ≥ 1,5 x upper limit of normal range SGOT (ASAT) and SGPT (ALAT) ≥ 2,5 x upper limit of normal range Alkaline phosphatase ≥ 2,5 x upper limit of normal range
- Hereditary Intrinsic Platelet Disorders
- Ongoing irradiation or chemotherapy (within the last 4 weeks)
- Estimated life expectancy of less than 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents - A Phase II Study HIT-HGG-CilMetro - A Clinical Phase II Trial of the HIT-HGG Study Group -
The primary objective of this study is to evaluate the efficacy of a combined treatment with cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS) after diagnosis of relapse or tumour progression in children and adolescents with relapsed or refractory high-grade malignant glioma and diffuse intrinsic pontine glioma.
Secondary objectives include:
Read more
- To evaluate the safety and toxicity of the study treatment by common toxicity criteria (CTC; version 4.0).
- To assess
- the response rates at 6 months (continuous complete response = CCR, complete response = CR, partial response = PR, stable disease = SD, progressive disease = PD) and
- progression-free survival (PFS) at 6 months, and
- response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of tumor progression. Response will be presented including histopathological variants.
- To assess the pharmacokinetics of cilengitide administered as part of the study treatment.
Indication and study population for this trial:
Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas in paediatric patients ≥ 3 years and < 18 years of age.
Patients included in the study receive
- Cilengitide 1800 mg/m² i.v. twice weekly
- Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely: Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50 - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until platelet recovery ≥ 100 000/µl (≥100 Gpt/l)
- Study treatment in the individual patient is scheduled for 1 year unless tumor progression or excessive toxicity occurs. However, study treatment may be extended beyond 1 year upon individual decision.
Read the detailed description
Indication:
Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas in paediatric patients ≥ 3 years and < 18 years of age.
Background and rationale:
Relapsed or refractory high-grade gliomas or diffuse intrinsic pontine gliomas (in the following both addressed as high grade gliomas = HGG) in children and adolescents represent a very bad prognosis group for which a recommended standard salvage therapy is currently not available.
The combination of cilengitide and metronomic temozolomide will be investigated in the present trial as new treatment strategy for these patients.
Metronomic temozolomide was shown to act via inhibition of tumour angiogenesis and as a cytotoxic agent. Cilengitide might act via tumour angiogenesis and also inhibits tumour cell migration.
For both drugs, safe doses with only low toxicity had been defined in phase I trials for paediatric patients with recurrent or refractory brain tumours (Cilengitide: 1800 mg/m² twice weekly; metronomic Temozolomide: 75-80 mg/m²/d in a 6 week schedule followed by one week rest) In a phase II trial for adult patients with relapsed glioblastoma cilengitide as single agent showed a trend towards higher efficacy with 2000 mg twice weekly as compared to 500 mg twice weekly. Furthermore, in a phase II trial of newly diagnosed adult glioblastoma patients, signs of clinical activity of cilengitide in combination with radiotherapy and conventional temozolomide was seen in the methylated MGMT gene promoter subgroup. Based on these findings, a large randomized phase III trial investigating cilengitide in combination with standard therapy (temozolomide and radiation) in this subgroup was started recently.
Metronomic temozolomide was also shown to be still effective in glioma patients suffering from relapse after temozolomide standard therapy. Interestingly, the mode of action appears to be widely independent of the MGMT status, probably due to MGMT depletion by continuous treatment.
In conclusion, for both drugs signs of clinical activity have been shown in relapsed glioblastoma patients, even after failure of temozolomide standard therapy.
Study design:
Prospective, non-randomized phase II trial.
Study population:
Patients 3 years and < 18 years of age with high grade glioma or diffuse intrinsic pontine glioma relapsed after or refractory to standard therapy recruited by approved trial sites
Sample size:
It is planned to include 33 patients.
Therapy:
Patients included in the study receive
- Cilengitide 1800 mg/m² i.v. twice weekly
- Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely: Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50 - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until platelet recovery ≥ 100 000/µl (≥100 Gpt/l)
- Study treatment in the individual patient is scheduled for 1 year unless tumor progression or excessive toxicity occurs. However, study treatment may be extended beyond 1 year upon individual decision.
Biometry:
Statistical analysis and sample size calculation:
The feasibility and efficacy of the HIT-HGG-CilMetro therapy will be assessed by a single stage analysis. Sample size calculation is based on the 6 month overall survival rate. This survival rate was found to be 44% in a historical study population from the HIT-GBM data base. An overall survival rate of 59% in the present study is considered to be of clinical relevance. Based on a one sided one sample χ2-test and a significance level α=5% a sample size of 33 patients is planned. This sample size implies a power of 50%.
Schedule:
The study is scheduled to start on January 1, 2012. The recruitment period for the trial will last 24 months until December 31, 2013. Individual follow-up for at least 1 year after study entry is required for this protocol. The study will be finished 30 days after completion of study treatment of the last patient enrolled, i.e. the expected end of the trial will be January 31, 2015.
Long-term follow-up is strongly recommended and will be organised via the HIT-HGG Study Office.
If the start of the study is delayed, given dates will change accordingly.
Financial support:
Merck KGaA, Darmstadt, Germany, provides a grant for the conduct of the trial, supplies Cilengitide free of charge and agrees to perform the laboratory assessments for pharmacokinetics.
- Conditions
- Gliomas
- Being tested
- Cilengitide, Temozolomide
- Keywords
- High grade glioma, Glioblastoma multiforme, Anaplastic astrocytoma, Diffuse intrinsic pontine glioma, Relapse, refractory tumour disease, Relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma, Diffuse Intrinsic Pontine Glioma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilengitideDrug
Also called EMD 121974
Cilengitide 1800 mg/m² i.v. twice weekly with a mandatory platelet-count dependent dose adaptation rule
TemozolomideDrug
Also called Temodal
Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule
| Study group | Role | What they receive |
|---|---|---|
| Cilengitide and metronomic temozolomide | Experimental | Cilengitide 1800 mg/m² i.v. twice weekly and Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule Receives: Drug: Cilengitide; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a combined treatment with cilengitide and temozolomide as measured by 6 months overall survival after diagnosis of relapsed or refractory high grade glioma or diffuse intrinsic pontine glioma in children and adolescents
Evaluation of overall survival after 6 months
Measured: 6 months
Secondary outcomes (3)
Safety and toxicity of the study treatment
Evaluation of safety and toxicity of the study treatment by NCI Common Toxicity Criteria (CTC; version 4.0) for up to 30 days after the end of study treatment which may last up to 52 weeks.
Toxic events defined as CTC grade 4 toxicities and deaths caused by therapy (CTC grade 5) excluding haematological toxicities (CTC grade 1-4)will be immediately assessed after documentation, and probability for such a toxic event statistically evaluated to ensure that this probability is within the predefined range (p1=15%).
Measured: Up to 52 weeks of treatment and subsequently 30 days after end of treatment
Response rates (RR) at 6 months, progression-free survival (PFS) at 6 months, and RR, overall survival (OS), and PFS at 12 months after relapse diagnosis or diagnosis of tumor progression
Evaluation of RR (continuous complete response = CCR, complete response = CR, partial response = PR, stable disease = SD, progressive disease = PD) by MRI and PFS (defined as survival from date of first progression/relapse to first documented date of second progression/relapse) after 6 and 12 months.
Evaluation of OS after 12 months
Measured: Response rates and progression-free survival at 6 and 12 months, overall survival at 12 months (Trial subjects will be followed up for at least 1 year and 30 days after study entry)
Peak plasma levels of cilengitide [ng/ml] on day 1 of week 1 and day 4 of week 6
Assessment of cilengitide serum levels [ng/ml] by a validated liquid chromatograpy tandem mass spectrometry assay on day 1 of week (before, immediately after, and 2, 4, 7 hours after cilengitide administration) and day 4 of week 6 (2 hours after cilengitide administration)
Measured: Day 1 of treatment week 1: Immediately before and immediately after as well as 2, 4, and 7 hours after end of cilengitide administration; day 4 of treatment week 6: 2 hours after end of cilengitide adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionApr 2014
Why it stopped: due to an altered benefit/risk assessment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomasStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Principal investigator, Christof Kramm, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Christof M. Kramm, MD, Study chair, University Children´s Hospital, Halle, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517776
- Sponsor's protocol ID
- HIT-HGG-CilMetro
- Other IDs
- 2009-011898-33, 2009
- Acronym
- HGG-CilMetro
- Status last verified
- Jun 2015
- First submitted
- 11 Jan 2012
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents - A Phase II Study HIT-HGG-CilMetro - A Clinical Phase II Trial of the HIT-HGG Study Group -
- ClinicalTrials.gov ID
- NCT01517776
- Acronym / sponsor ID
- HGG-CilMetro / HIT-HGG-CilMetro
- Conditions
- Gliomas
- Keywords
- High grade glioma, Glioblastoma multiforme, Anaplastic astrocytoma, Diffuse intrinsic pontine glioma, Relapse, refractory tumour disease, Relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to an altered benefit/risk assessment.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jan 2012 (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.
The primary objective of this study is to evaluate the efficacy of a combined treatment with cilengitide and metronomic oral temozolomide as measured by 6 months overall survival (OS) after diagnosis of relapse or tumour progression in children and adolescents with relapsed or refractory high-grade malignant glioma and diffuse intrinsic pontine glioma.
Secondary objectives include:
- To evaluate the safety and toxicity of the study treatment by common toxicity criteria (CTC; version 4.0).
- To assess
- the response rates at 6 months (continuous complete response = CCR, complete response = CR, partial response = PR, stable disease = SD, progressive disease = PD) and
- progression-free survival (PFS) at 6 months, and
- response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of tumor progression. Response will be presented including histopathological variants.
- To assess the pharmacokinetics of cilengitide administered as part of the study treatment.
Indication and study population for this trial:
Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas in paediatric patients ≥ 3 years and < 18 years of age.
Patients included in the study receive
- Cilengitide 1800 mg/m² i.v. twice weekly
- Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely: Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50 - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until platelet recovery ≥ 100 000/µl (≥100 Gpt/l)
- Study treatment in the individual patient is scheduled for 1 year unless tumor progression or excessive toxicity occurs. However, study treatment may be extended beyond 1 year upon individual decision.
Detailed description
Indication:
Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas in paediatric patients ≥ 3 years and < 18 years of age.
Background and rationale:
Relapsed or refractory high-grade gliomas or diffuse intrinsic pontine gliomas (in the following both addressed as high grade gliomas = HGG) in children and adolescents represent a very bad prognosis group for which a recommended standard salvage therapy is currently not available.
The combination of cilengitide and metronomic temozolomide will be investigated in the present trial as new treatment strategy for these patients.
Metronomic temozolomide was shown to act via inhibition of tumour angiogenesis and as a cytotoxic agent. Cilengitide might act via tumour angiogenesis and also inhibits tumour cell migration.
For both drugs, safe doses with only low toxicity had been defined in phase I trials for paediatric patients with recurrent or refractory brain tumours (Cilengitide: 1800 mg/m² twice weekly; metronomic Temozolomide: 75-80 mg/m²/d in a 6 week schedule followed by one week rest) In a phase II trial for adult patients with relapsed glioblastoma cilengitide as single agent showed a trend towards higher efficacy with 2000 mg twice weekly as compared to 500 mg twice weekly. Furthermore, in a phase II trial of newly diagnosed adult glioblastoma patients, signs of clinical activity of cilengitide in combination with radiotherapy and conventional temozolomide was seen in the methylated MGMT gene promoter subgroup. Based on these findings, a large randomized phase III trial investigating cilengitide in combination with standard therapy (temozolomide and radiation) in this subgroup was started recently.
Metronomic temozolomide was also shown to be still effective in glioma patients suffering from relapse after temozolomide standard therapy. Interestingly, the mode of action appears to be widely independent of the MGMT status, probably due to MGMT depletion by continuous treatment.
In conclusion, for both drugs signs of clinical activity have been shown in relapsed glioblastoma patients, even after failure of temozolomide standard therapy.
Study design:
Prospective, non-randomized phase II trial.
Study population:
Patients 3 years and < 18 years of age with high grade glioma or diffuse intrinsic pontine glioma relapsed after or refractory to standard therapy recruited by approved trial sites
Sample size:
It is planned to include 33 patients.
Therapy:
Patients included in the study receive
- Cilengitide 1800 mg/m² i.v. twice weekly
- Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule: mandatory blood counts twice weekely: Platelets ≥ 100 000/µl (≥ 100 Gpt/l): 75 mg/m², platelets ≥ 50 000 - < 100 000/µl (≥ 50 - <100 Gpt/l): 50 mg/m², platelets < 50 000/µl (<50 Gpt/l): stop temozolomide until platelet recovery ≥ 100 000/µl (≥100 Gpt/l)
- Study treatment in the individual patient is scheduled for 1 year unless tumor progression or excessive toxicity occurs. However, study treatment may be extended beyond 1 year upon individual decision.
Biometry:
Statistical analysis and sample size calculation:
The feasibility and efficacy of the HIT-HGG-CilMetro therapy will be assessed by a single stage analysis. Sample size calculation is based on the 6 month overall survival rate. This survival rate was found to be 44% in a historical study population from the HIT-GBM data base. An overall survival rate of 59% in the present study is considered to be of clinical relevance. Based on a one sided one sample χ2-test and a significance level α=5% a sample size of 33 patients is planned. This sample size implies a power of 50%.
Schedule:
The study is scheduled to start on January 1, 2012. The recruitment period for the trial will last 24 months until December 31, 2013. Individual follow-up for at least 1 year after study entry is required for this protocol. The study will be finished 30 days after completion of study treatment of the last patient enrolled, i.e. the expected end of the trial will be January 31, 2015.
Long-term follow-up is strongly recommended and will be organised via the HIT-HGG Study Office.
If the start of the study is delayed, given dates will change accordingly.
Financial support:
Merck KGaA, Darmstadt, Germany, provides a grant for the conduct of the trial, supplies Cilengitide free of charge and agrees to perform the laboratory assessments for pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cilengitide and metronomic temozolomide | Experimental | Drug: Cilengitide, Drug: TemozolomideCilengitide 1800 mg/m² i.v. twice weekly and Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of high-grade malignant glioma confirmed by central neuropathological review (last MRI diagnosis not older than 4 weeks) - including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (analogous to WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV) - or diagnosis of diffuse intrinsic pontine glioma confirmed by central neuroradiological review - refractory to standard treatment, or relapsed or progressive after first-line therapy.
- Patient aged 3 years and older but under 18 years at time of relapse diagnosis
- Written informed consent of the patient (mandatory from 15 years of age) or the parents (mandatory till 18 years of age).
Key exclusion criteria (14 listed)
- Known hypersensitivity or contraindication to any study drugs
- Other (simultaneous) malignancies
- Pregnancy and / or lactation
- Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
- Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
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 |
|---|---|---|
| CilengitideAlso: EMD 121974Cilengitide 1800 mg/m² i.v. twice weekly with a mandatory platelet-count dependent dose adaptation rule | Drug | Cilengitide and metronomic temozolomide |
| TemozolomideAlso: TemodalTemozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule | Drug | Cilengitide and metronomic temozolomide |
Primary outcome
Efficacy of a combined treatment with cilengitide and temozolomide as measured by 6 months overall survival after diagnosis of relapsed or refractory high grade glioma or diffuse intrinsic pontine glioma in children and adolescents
Time frame: 6 months
Evaluation of overall survival after 6 months
3 secondary outcomes
Safety and toxicity of the study treatment
Time frame: Up to 52 weeks of treatment and subsequently 30 days after end of treatment
Response rates (RR) at 6 months, progression-free survival (PFS) at 6 months, and RR, overall survival (OS), and PFS at 12 months after relapse diagnosis or diagnosis of tumor progression
Time frame: Response rates and progression-free survival at 6 and 12 months, overall survival at 12 months (Trial subjects will be followed up for at least 1 year and 30 days after study entry)
Peak plasma levels of cilengitide [ng/ml] on day 1 of week 1 and day 4 of week 6
Time frame: Day 1 of treatment week 1: Immediately before and immediately after as well as 2, 4, and 7 hours after end of cilengitide administration; day 4 of treatment week 6: 2 hours after end of cilengitide adminstration
Results and safety
The study was stopped early (reason given: due to an altered benefit/risk assessment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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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.
Christof M. Kramm, MD study chair
University Children´s Hospital, Halle, Germany
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 Cilengitide and Temozolomide in people with Gliomas, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Jul 2015. 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 Germany. 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 was stopped early (reason given: due to an altered benefit/risk assessment.). Results are not available in the source record.
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?
Efficacy of a combined treatment with cilengitide and temozolomide as measured by 6 months overall survival after diagnosis of relapsed or refractory high grade glioma or diffuse intrinsic pontine glioma in children and adolescents (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2015.