AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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
  • Fondazione Istituto Nazionale dei Tumori

    Milan, 20133

    Contact Person, 39-02-2390-2532, alessandro.gianni@unimi.it

    Recruiting

Other trials in Italy

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.
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy

  2. Toxicity

  3. 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.

  1. First posted30 Jul 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2012 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in