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Brain and Central Nervous System TumorsPhase 2NCT00470366

Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

A Phase 2 study testing pegfilgrastim, cisplatin and ifosfamide in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
pegfilgrastim, cisplatin and ifosfamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Mar 2007to Jun 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed germ cell tumor meeting 1 of the following criteria:
  • Poor risk, defined by any of the following:
  • Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
  • Pretreatment serum lactate dehydrogenase (LDH) > 10 times upper limit of normal (ULN)
  • Pretreatment serum human chorionic gonadotropin (HCG) > 50,000 IU/L
  • Pretreatment serum alpha fetoprotein (AFP) > 10,000 ng/mL
  • Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
  • Bone metastases
  • Brain metastases
  • Hepatic metastases
  • Any nonpulmonary metastases (i.e., skin, spleen)
  • Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
  • Modified intermediate risk, defined by any of the following:
  • Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
  • Pretreatment serum LDH 3.0-10 times ULN
  • Pretreatment serum HCG 5,000-50,000 IU/L
  • Pretreatment serum AFP 1,000-10,000 ng/mL
  • Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
  • Bone metastases
  • Brain metastases
  • Hepatic metastases
  • Any nonpulmonary visceral metastases (i.e., skin, spleen)
  • Previously untreated disease
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine normal or creatinine clearance > 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
  • AST and ALT ≤ 3 times ULN
  • Bilirubin ≤ 2.0 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent malignancy except for nonmelanoma skin cancer
  • No known HIV positivity
  • No active infections

PRIOR CONCURRENT THERAPY:

  • Recovered from prior surgery
  • More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
  • No prior chemotherapy
  • No other concurrent cytotoxic therapy
  • Concurrent radiotherapy and surgery allowed for treatment of brain metastases

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors.
  • Determine the safety of this regimen in these patients.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.

After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Keywords
stage II malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular seminoma, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor, stage I malignant testicular germ cell tumor, adult central nervous system germ cell tumor, ovarian choriocarcinoma
Medical subject headings
Central Nervous System Neoplasms, Ovarian Neoplasms, Teratoma, Testicular Germ Cell Tumor, Testicular Neoplasms, Carcinoma, Embryonal, Seminoma, Endodermal Sinus Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00470366
Study groupRoleWhat they receive
Paclitaxel, Ifosfamide, and CisplatinExperimental-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
Receives: Biological: pegfilgrastim; Drug: cisplatin; Drug: ifosfamide; Drug: paclitaxel

What is being measured

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

  1. Rate of Complete Response

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions

    Measured: 3 years

Secondary outcomes (3)

  1. Progression-free Survival

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: Up to 8 years

  2. Percentage of Participants With Progression Free Survival

    Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 3 years

  3. Number of Patients With Treatment Related Toxicity

    Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionJun 2016
  4. Study completionJun 2016

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00470366
Sponsor's protocol ID
07-044
Other IDs
MSKCC-07044
Status last verified
Jun 2016
First submitted
3 May 2007
Last updated
28 Nov 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim, cisplatin and ifosfamide in people with Brain and Central Nervous System Tumors and Extragonadal Germ Cell Tumor, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

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: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 24 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Rate of Complete Response (time frame: 3 years). 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 NCT00470366.

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 28 Nov 2017.

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