MalignancyPhase 1NCT01242072
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
A Phase 1 study testing palifosfamide-tris in people with Malignancy and Cancer, run by Alaunos Therapeutics at 4 sites in United States.
Trial summary
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy, Cancer, Non Small Cell Lung Cancer
- What is being tested?
- palifosfamide-tris
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to 16 Jul 2012
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or greater
- Malignancy scheduled to receive etoposide and carboplatin therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Adequate bone marrow, liver, renal function and coagulation status
- Informed consent
- Agree to use birth control through 28 days of last treatment dose
- Pregnancy test for women of child-bearing potential
- No available standard therapy
Who cannot join
- Allergy to the the study treatment drugs
- Unstable current medical condition
- Presence or history of injury to the urinary tract
- Active infection
- Major surgery within 4 weeks prior to treatment
- Minor surgery within 2 weeks prior to treatment
Show all 11Show fewer
- Current acute steroid therapy or taper
- Currently pregnant or nursing
- Substance abuse or condition that may interfere with participation
- Received other investigational drugs within 30 days
- Within 4 weeks of their last chemotherapy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
Horizon Oncology Research
Lafayette, Indiana, 47905
Medical Consultants, PC
Muncie, Indiana, 47303
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
- Conditions
- Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma
- Being tested
- palifosfamide-tris
- Keywords
- malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Testicular Neoplasms, Thymoma, Ovarian Neoplasms, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palifosfamide-trisDrug
Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| PaCE | Experimental | Palifosfamide, Carboplatin and Etoposide Receives: Drug: palifosfamide-tris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety profile
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
Measured: 21 Days
Secondary outcomes (2)
Determine the maximum tolerated dose
Each dose level cohort will be 3 subjects. After 3 subjects have received a regimen, there will be a minimum observation period of 1 full cycle (21 days) for each of the 3 subjects before enrollment of the group of subjects at the next dose level.
Measured: Up to 21 days
Assess early signs of efficacy
To assess early signs of efficacy using this investigational combination in this patient population
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startDec 2010
- Primary completion16 Jul 2012
- Study completion16 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242072
- Sponsor's protocol ID
- IPM1004
- Status last verified
- Sep 2026
- First submitted
- 12 Nov 2010
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice
- ClinicalTrials.gov ID
- NCT01242072
- Acronym / sponsor ID
- IPM1004
- Conditions
- Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma
- Keywords
- malignancy, etoposide and carboplatin, non small cell lung cancer, small cell lung cancer, testicular cancer, thymoma, ovarian cancer, osteosarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- 16 Jul 2012 (actual)
- Study completion
- 16 Jul 2012 (actual)
- First posted
- 16 Nov 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.
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PaCE | Experimental | Drug: palifosfamide-trisPalifosfamide, Carboplatin and Etoposide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old or greater
- Malignancy scheduled to receive etoposide and carboplatin therapy
- Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
- Adequate bone marrow, liver, renal function and coagulation status
- Informed consent
Key exclusion criteria (11 listed)
- Allergy to the the study treatment drugs
- Unstable current medical condition
- Presence or history of injury to the urinary tract
- Active infection
- Major surgery within 4 weeks prior to treatment
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 |
|---|---|---|
| palifosfamide-trisIntravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles | Drug | PaCE |
Primary outcome
Assess the safety profile
Time frame: 21 Days
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
2 secondary outcomes
Determine the maximum tolerated dose
Time frame: Up to 21 days
Assess early signs of efficacy
Time frame: duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing palifosfamide-tris in people with Malignancy and Cancer, run by Alaunos Therapeutics at 4 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the safety profile (time frame: 21 Days). 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 29 Sep 2026.