Brain and Central Nervous System TumorsPhase 2NCT01172912
High-Dose Chemotherapy and Stem Cell Transplant in Treating Patients With Metastatic Germ Cell Tumors That Have Not Responded to First-Line Therapy
A Phase 2 study testing filgrastim, pegfilgrastim and carboplatin in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
- What is being tested?
- filgrastim, pegfilgrastim and carboplatin
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Oct 2012
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed germ cell tumor (GCT) based on pathologic review at INT Milan
- Metastatic disease
- Relapsed or refractory disease
- Prior chemotherapy treatment for GCT without a pathologic diagnosis due to unequivocal clinical evidence of GCT and an urgent need to start therapy (elevated alpha-fetoprotein [AFP] or human chorionic gonadotropin [HCG] with pattern of metastases consistent with GCT and high tumor burden) allowed
- Unequivocal progression of measurable disease, consisting of abnormalities on 2-dimensional imaging or raised tumor markers, following 1 line of cisplatin-based chemotherapy as documented by either of the following:
- Tumor biopsy of new, growing, or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after resection of viable GCT not allowed)
- Increasing or abnormally elevated serum tumor markers (HCG or AFP) (increasing lactate dehydrogenase [LDH] alone does not constitute progressive disease)
- Received ≥ 3 and ≤ 6, cisplatin-based chemotherapy courses as part of first-line (initial) chemotherapy and ≤ 6 cisplatin-based chemotherapy courses
- Brain metastases allowed
- May be treated with radiotherapy and/or surgery concurrently with cisplatin, ifosfamide, and etoposide regimen
- Radiotherapy should not be given concurrently with mobilization phase/leukapheresis and high-dose carboplatin and etoposide
PATIENT CHARACTERISTICS:
- WBC ≥ 2,000/µL
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Creatinine clearance ≥ 50 cc/min (unless renal dysfunction is due to tumor obstructing the ureters, in which case eligibility will be determined by the principal investigator)
- AST/ALT < 2 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic metastases)
- Total bilirubin < 1.5 times ULN
- Ejection fraction ≥ 50% by echocardiogram
- Negative serology for the following infectious diseases:
- HIV type 1 and 2
- Hepatitis B surface antigen (active carriers)
- Hepatitis C
- Cytomegalovirus (serum Ag p65 ± PCR confirmation at principal investigator discretion)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior surgery
- At least 3 weeks since prior chemotherapy
- No prior high-dose chemotherapy with peripheral blood stem cell rescue
- No more than 1 prior chemotherapy regimen for metastatic disease
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Istituto Nazionale dei Tumori
Milan, 20133
Contact Person, 39-02-2390-2532, alessandro.gianni@unimi.it
About this study
Official title: Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.
Read the detailed description
OBJECTIVES:
- To evaluate the efficacy of high-dose chemotherapy comprising carboplatin and etoposide (CE) in combination with autologous hematopoietic stem cell transplantation using the CE regimen as initial salvage treatment in patients with relapsed or refractory, metastatic germ cell tumors that did not respond to first-line treatment.
- To evaluate the toxicity associated with this regimen in these patients.
- To evaluate biological correlates of outcome in patients with available tissue pre- and post-treatment.
OUTLINE:
- Conventional-dose chemotherapy: Patients receive ifosfamide on days 1 and 2, followed by cisplatin and etoposide on days 3-5, and dexamethasone on days 1-5. Patients undergo leukapheresis daily for stem cell harvest. Patients also receive conventional filgrastim (G-CSF) subcutaneously (SC) once a day beginning 48 hours after completion of chemotherapy until adequate collection of stem cells are obtained. Treatment repeats every 21 days for 1 or 2 courses.
- High-dose (HD) chemotherapy: Patients receive HD carboplatin and etoposide once a day on days 1-3. Treatments repeat every 30-40 days for 2 courses.
- Autologous hematopoietic stem cell transplantation: Patients undergo reinfusion of autologous stem cells on day 6 (after HD chemotherapy on days 1-5). Patients then receive one dose of pegfilgrastim SC beginning 6 hours after completion of stem cell infusion or conventional filgrastim SC once daily beginning 4 days after completion of stem cell infusion and continuing until blood counts recover.
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
- Being tested
- filgrastim, pegfilgrastim, carboplatin, cisplatin, dexamethasone
- Keywords
- recurrent extragonadal germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV extragonadal non-seminomatous germ cell tumor, stage III malignant testicular germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal seminoma, testicular mature teratoma, adult central nervous system germ cell tumor, testicular immature teratoma
- Medical subject headings
- Central Nervous System Neoplasms, Testicular Germ Cell Tumor, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
pegfilgrastimBiological
carboplatinDrug
cisplatinDrug
dexamethasoneDrug
etoposideDrug
ifosfamideDrug
high-dose chemotherapy with autologous stem cell rescueOther
laboratory biomarker analysisOther
autologous hematopoietic stem cell transplantationProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Toxicity
Biological correlates of outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe 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
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Alessandro M. Gianni, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172912
- Sponsor's protocol ID
- ITA-MIL-INT-38-10
- Other IDs
- CDR0000682204, EUDRACT-2010-021898-36, EU-21054
- Status last verified
- Aug 2011
- First submitted
- 29 Jul 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tandem High-Dose Chemotherapy (HDCT) With Peripheral-Blood Stem-Cell Rescue for Patients With Metastatic Germ-Cell Tumors Failing First-Line Treatment
- ClinicalTrials.gov ID
- NCT01172912
- Acronym / sponsor ID
- ITA-MIL-INT-38-10
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
- Keywords
- recurrent extragonadal germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent malignant testicular germ cell tumor, stage IV extragonadal non-seminomatous germ cell tumor, stage III malignant testicular germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal seminoma, testicular mature teratoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- First posted
- 30 Jul 2010 (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.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying the side effects of giving high-dose chemotherapy together with stem cell transplant and to see how well it works in treating patients with metastatic germ cell tumors that have not responded to first-line therapy.
Detailed description
OBJECTIVES:
- To evaluate the efficacy of high-dose chemotherapy comprising carboplatin and etoposide (CE) in combination with autologous hematopoietic stem cell transplantation using the CE regimen as initial salvage treatment in patients with relapsed or refractory, metastatic germ cell tumors that did not respond to first-line treatment.
- To evaluate the toxicity associated with this regimen in these patients.
- To evaluate biological correlates of outcome in patients with available tissue pre- and post-treatment.
OUTLINE:
- Conventional-dose chemotherapy: Patients receive ifosfamide on days 1 and 2, followed by cisplatin and etoposide on days 3-5, and dexamethasone on days 1-5. Patients undergo leukapheresis daily for stem cell harvest. Patients also receive conventional filgrastim (G-CSF) subcutaneously (SC) once a day beginning 48 hours after completion of chemotherapy until adequate collection of stem cells are obtained. Treatment repeats every 21 days for 1 or 2 courses.
- High-dose (HD) chemotherapy: Patients receive HD carboplatin and etoposide once a day on days 1-3. Treatments repeat every 30-40 days for 2 courses.
- Autologous hematopoietic stem cell transplantation: Patients undergo reinfusion of autologous stem cells on day 6 (after HD chemotherapy on days 1-5). Patients then receive one dose of pegfilgrastim SC beginning 6 hours after completion of stem cell infusion or conventional filgrastim SC once daily beginning 4 days after completion of stem cell infusion and continuing until blood counts recover.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| filgrastim | Biological | – |
| pegfilgrastim | Biological | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| dexamethasone | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| high-dose chemotherapy with autologous stem cell rescue | Other | – |
| laboratory biomarker analysis | Other | – |
| autologous hematopoietic stem cell transplantation | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Efficacy
Toxicity
Biological correlates of outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Brain and Central Nervous System Tumors
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
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.
Alessandro M. Gianni, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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 filgrastim, pegfilgrastim and carboplatin in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. The study lists 3 primary outcomes in all. 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 12 Aug 2013.