Advanced SarcomaPhase 1/2NCT00439686
Study of ZIO-201 in Advanced Sarcoma
A Phase 1/2 study testing ZIO-201 in people with Advanced Sarcoma, run by Alaunos Therapeutics at 2 sites in United States.
Trial summary
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Sarcoma
- What is being tested?
- ZIO-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2006to 16 Jan 2008
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Metastatic and /or unresectable disease state after previous standard chemotherapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Ann Arbor, Michigan
Study site
Santa Monica, California
About this study
Official title: A Phase IB/IIA Study of the Safety and Activity of Intravenous Isophosphoramide Mustard (ZIO-201) in Patients With Advanced Sarcoma
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.
- Conditions
- Advanced Sarcoma
- Being tested
- ZIO-201
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZIO-201Drug
Also called palifosfamide
Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Palifosfamide-lysine 590 mg/m² | Experimental | Participants received palifosfamide-lysine 590 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Four participants were treated at this dose level. Dose escalation was discontinued after 2 of 4 participants experienced dose-limiting toxicities during Cycle 1. Receives: Drug: ZIO-201 |
| Phase 2: Palifosfamide-lysine 413 mg/m² | Experimental | Participants received palifosfamide-lysine 413 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Forty-nine participants were treated at this dose level. The last 6 participants enrolled also participated in a pharmacokinetic substudy in which they received a single dose of palifosfamide-tris 178 mg/m² on Day -14 before beginning palifosfamide-lysine treatment. Receives: Drug: ZIO-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following:
a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT.
Measured: Cycle 1 (21 days)
Secondary outcomes (2)
Maximum Plasma Concentration (Cmax) of Palifosfamide
Cmax of palifosfamide, measured from blood samples collected during Cycle 1 dosing.
Measured: Cycle 1, Days 1 to 3
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Palifosfamide
AUC0-inf of palifosfamide, measured from blood samples collected during Cycle 1 dosing.
Measured: Cycle 1, Days 1 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2007 (estimated)
- Study start21 Feb 2006
- Primary completion16 Jan 2008
- Study completion16 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced SarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This Phase 1/Phase 2, open-label study included a Phase 1 dose cohort treated with palifosfamide-lysine 590 mg/m² and a Phase 2 cohort treated with palifosfamide-lysine 413 mg/m². Dose escalation was stopped after 2 of 4 participants at 590 mg/m² experienced dose-limiting toxicities. The dose was subsequently reduced to 413 mg/m² for the Phase 2 portion. The last 6 Phase 2 participants also participated in a pharmacokinetic substudy of palifosfamide-tris.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Lewis, MD, PhD, Study director, ZIOPHARM Oncology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439686
- Sponsor's protocol ID
- IPM2001
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2007
- Last updated
- 5 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB/IIA Study of the Safety and Activity of Intravenous Isophosphoramide Mustard (ZIO-201) in Patients With Advanced Sarcoma
- ClinicalTrials.gov ID
- NCT00439686
- Acronym / sponsor ID
- IPM2001
- Conditions
- Advanced Sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2006 (actual)
- Primary completion
- 16 Jan 2008 (actual)
- Study completion
- 16 Jan 2008 (actual)
- First posted
- 26 Feb 2007 (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.
The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This Phase 1/Phase 2, open-label study included a Phase 1 dose cohort treated with palifosfamide-lysine 590 mg/m² and a Phase 2 cohort treated with palifosfamide-lysine 413 mg/m². Dose escalation was stopped after 2 of 4 participants at 590 mg/m² experienced dose-limiting toxicities. The dose was subsequently reduced to 413 mg/m² for the Phase 2 portion. The last 6 Phase 2 participants also participated in a pharmacokinetic substudy of palifosfamide-tris.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Palifosfamide-lysine 590 mg/m² | Experimental | Drug: ZIO-201Participants received palifosfamide-lysine 590 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Four participants were treated at this dose level. Dose escalation was discontinued after 2 of 4 participants experienced dose-limiting toxicities during Cycle 1. |
| Phase 2: Palifosfamide-lysine 413 mg/m² | Experimental | Drug: ZIO-201Participants received palifosfamide-lysine 413 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Forty-nine participants were treated at this dose level. The last 6 participants enrolled also participated in a pharmacokinetic substudy in which they received a single dose of palifosfamide-tris 178 mg/m² on Day -14 before beginning palifosfamide-lysine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| ZIO-201Also: palifosfamidePalifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions. | Drug | Phase 1: Palifosfamide-lysine 590 mg/m², Phase 2: Palifosfamide-lysine 413 mg/m² |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
Time frame: Cycle 1 (21 days)
DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following: a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT.
2 secondary outcomes
Maximum Plasma Concentration (Cmax) of Palifosfamide
Time frame: Cycle 1, Days 1 to 3
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Palifosfamide
Time frame: Cycle 1, Days 1 to 3
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 5 Oct 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.
Jonathan Lewis, MD, PhD study director
ZIOPHARM Oncology, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZIO-201 in people with Advanced Sarcoma, run by Alaunos Therapeutics 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 5 Oct 2026. 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 combined 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.
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?
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?
Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1 (time frame: Cycle 1 (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 5 Oct 2026.