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Adult Central Nervous System Germ Cell TumorPhase 2NCT01808534

Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors

A Phase 2 study testing palifosfamide in people with Adult Central Nervous System Germ Cell Tumor and Adult Teratoma, run by Indiana University at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
palifosfamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesUnited States
Study dates
Feb 2013to Nov 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histological or serological proof of metastatic germ cell neoplasm (gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy; patients with seminoma and nonseminoma are eligible, as are women with ovarian germ cell tumors
  • Patients must have evidence of recurrent or metastatic carcinoma by one or more of the criteria specified in the protocol
  • Patients must have received initial cisplatin based combination therapy (such as bleomycin, etoposide and cisplatin [BEP], etoposide and cisplatin [EP], VP-16 plus ifosfamide plus cisplatin [VIP] or similar regimens) AND demonstrated progression following the administration of at least one 'salvage' regimen for advanced germ cell neoplasm (such as high dose chemotherapy, paclitaxel/ifosfamide/cisplatin [TIP] or vinblastine, ifosfamide and cisplatin [VeIP])
  • Patients must have documented "failure" of prior therapy as defined in the protocol
  • Patients are eligible after first line platinum based chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor (PMNSGCT) or late relapse (> 2 years) not amenable to surgical resection
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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  • Laboratory test results must be within ranges established in the protocol
  • Potential subject must have the ability to understand (as judged by the treating physician) and willingness to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information;
  • Females of childbearing potential must not be pregnant or breast-feeding; male and female patients of reproductive potential must agree to use a highly reliable method of birth control from the screening visit through 28 days after the last dose of study drug

Who cannot join

  • No active clinically serious infections as judged by the treating investigator (> CTCAE grade 2) including known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or active hepatitis C
  • No presence of, or history of any illness or injury to the urinary tract which may make the patient more susceptible to acute renal insufficiency in the case of potential renal adverse events
  • Patients must not have any cardiac disorders as defined in the protocol
  • No history of psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must be at least 4 weeks post major surgery or significant traumatic injury at time of study registration
  • Patients must be at least 7 days post any minor surgical procedure, excluding placement of a vascular access device at the time of study registration
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  • Patients must not have a known sensitivity to any component of palifosfamide or its known excipients
  • Patients with active central nervous system (CNS) metastases are excluded
  • Patients must not have previously been exposed to palifosfamide
  • Patients must have at least 3 weeks after previous radiotherapy or chemotherapy and have recovered from all major toxicities (except alopecia or grade 1 or 2 neuropathy) at the time of registration

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Abramson Cancer Center of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: Multicenter Single Arm Phase II Study of Single Agent Palifosfamide in Recurrent and Incurable Germ Cell Tumors

This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the response rate (complete response [CR]+partial response [PR]) of single agent palifosfamide in patients with refractory germ cell tumors.

SECONDARY OBJECTIVES:

  1. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors.

OUTLINE:

Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Being tested
palifosfamide
Medical subject headings
Teratoma, Testicular Neoplasms

What participants receive

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

  • palifosfamideDrug

    Also called IPM-lysine, isophosphoramide mustard-lysine, ZIO-201

    Given IV

Study groups in NCT01808534
Study groupRoleWhat they receive
Treatment (palifosfamide)ExperimentalPatients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: palifosfamide

What is being measured

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

  1. Overall Response Rate (Defined as Partial Response or Complete Response)

    The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Duration of Remission in Patients Who Achieve a Partial or Complete Response

    The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.

    Measured: Up to 2 years

  2. Progression Free Survival (PFS)

    Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.

    Measured: Up to 2 years

  3. Overall Survival

    Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.

    Measured: Up to 2 years

  4. Treatment Related Adverse Events Grade 3 or Higher

    Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

    Measured: Up to 2 years

Timeline

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

  1. First posted11 Mar 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionNov 2014
  4. Study completionNov 2014

Why it stopped: Due to Low Accrual

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
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01808534
Sponsor's protocol ID
IUCRO-0403
Other IDs
NCI-2013-00510, 1301010501
Status last verified
Jun 2015
First submitted
6 Mar 2013
Last updated
2 Jul 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing palifosfamide in people with Adult Central Nervous System Germ Cell Tumor and Adult Teratoma, run by Indiana University at 3 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?

The sponsor lists 9 inclusion and 10 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 2 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 3 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 2 Jul 2015). 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?

Overall Response Rate (Defined as Partial Response or Complete Response) (time frame: Up to 2 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 NCT01808534.

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 2 Jul 2015.

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