Soft Tissue SarcomaPhase 2PICASSONCT00718484
A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma
A Phase 2 study testing Palifosfamide-Tris and Doxorubicin in people with Soft Tissue Sarcoma, run by Alaunos Therapeutics at 23 sites in 3 countries.
Trial summary
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Palifosfamide-Tris and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 3 Sep 2008to 20 Sep 2010
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.
- Have measurable disease as per RECIST criteria (Appendix 2)
- ECOG Performance Status of 0 or 1 (Appendix 3)
- Anthracyclin naïve
- Life expectancy of ≥12 weeks
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- Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements conducted within 14 days prior to dosing:
- Hemoglobin ≥9.0 g/dL
- Absolute neutrophil count (ANC) ≥1,500/mm3
- Platelet count 100,000/mm3
- Total bilirubin ≤1.5×ULN (upper limit of normal)
- ALT and AST ≤2.5×ULN or 5×ULN with hepatic disease
- Partial thromboplastin [PT]-INR/activated partial thromboplastin time [PTT] <1.5×ULN (≤2.0×ULN for subjects on anticoagulation prophylactic regimen). Subjects who are being therapeutically anticoagulated with an agent such as Coumadin (warfarin sodium) or heparin are allowed provided there is no prior evidence of underlying abnormality in coagulation parameters. If an interaction between study drug and anticoagulant is suspected, anticoagulation monitoring should be increased as appropriate.
- Serum creatinine ≤ULN
- Written informed consent must be obtained from a potential subject prior to the conduct of any study-specific procedures
- Male and female subjects must agree to use adequate birth control measures/barrier control during the course of the trial
- Women of childbearing potential must have a urine pregnancy test performed within 14 days of the start of treatment
Who cannot join
- Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.
- Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)
- History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
- Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
- History of HIV infection
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- Prior nephrectomy or history of urinary tract obstruction
- Active, clinically serious infection requiring systemic antibacterial, antifungal, or antiviral therapy
- Any major surgery within 3 weeks prior to start of treatment
- Metastatic brain or meningeal tumors, unless the subject is >6 months from definitive therapy and has a negative imaging study within 4 weeks of study entry. In addition, the subject must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable, provided the dose is stable for 1 month prior to study start, and following screening radiographic studies).
- Previous malignancy (except cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis, \& T1] or other malignancies curatively treated >5 years prior to entry)
- Pregnancy or lactation
- Substance abuse or medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Any condition that is unstable or could jeopardize the safety of a subject and his/her compliance with the protocol requirements
- In addition, use of the following therapies and medications-prior or concomitant-would exclude a subject from this study:
- Anticancer chemotherapy, immunotherapy, or any investigational drug therapy during the study or within 4 weeks of study entry (6 weeks for Mitomycin C)
- Prior treatment with doxorubicin
- Radiotherapy within 4 weeks of study entry (palliative radiation to bone lesions is permitted if started or planned prior to Cycle 1, Day 1)
- Bone marrow transplant or stem cell rescue within 4 months of study entry
- Growth factors such as G-CSF (granulocyte colony-stimulating factor/filgrastim), or biological response modifiers within 3 weeks of study entry
Trial locations and contacts
23 sites in 3 countries.
23 sites in 3 countries
United States18 sites
Study site
Albuquerque, New Mexico
Study site
Chicago, Illinois
Study site
Coeur d'Alene, Idaho, 83814
Study site
Durham, North Carolina
Study site
Iowa City, Iowa
Study site
Lenexa, Kansas
Study site
Memphis, Tennessee
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Park Ridge, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
Seattle, Washington
Study site
Tampa, Florida
Study site
Washington D.C., District of Columbia
About this study
Official title: A Phase II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Palifosfamide-Tris, Doxorubicin
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Doxorubicin, anthracyclin, Palifosfamide, IFOS
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palifosfamide-TrisDrug
Also called ZIO-201, isophosphoramide mustard
Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle.
DoxorubicinDrug
Also called Adriamycin
Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Palifosfamide-Tris Plus Doxorubicin | Experimental | Participants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment. Receives: Drug: Palifosfamide-Tris; Drug: Doxorubicin |
| Doxorubicin Alone With Optional Palifosfamide-Tris After Progression | Active comparator | Participants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment. Receives: Drug: Palifosfamide-Tris; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy analysis will be conducted on the intent-to-treat (ITT) population. All attempts will be made to conduct assessment of disease status every 6 weeks until progression of disease or initiating off protocol anti cancer therapies.
Measured: Every 6 weeks until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study start3 Sep 2008
- Primary completion20 Sep 2010
- Study completion20 Sep 2010
Why it stopped: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached. Enrolled participants were followed to their PFS endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized (1:1), open-label, parallel-group study. Arm A received palifosfamide 150 mg/m² IV on Days 1 to 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles, and could then continue single-agent palifosfamide. Arm B received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants in Arm B whose disease progressed at or before Cycle 6 could choose to switch to single-agent palifosfamide; this was optional and not a planned crossover.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan J Lewis, MD, PhD, Study director, ZIOPHARM Oncology, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718484
- Sponsor's protocol ID
- IPM2002
- Acronym
- PICASSO
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2008
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 II Multicenter, Parallel Group, Randomized Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Subjects With Unresectable or Metastatic Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00718484
- Acronym / sponsor ID
- PICASSO / IPM2002
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Doxorubicin, anthracyclin, Palifosfamide, IFOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached. Enrolled participants were followed to their PFS endpoint.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2008 (actual)
- Primary completion
- 20 Sep 2010 (actual)
- Study completion
- 20 Sep 2010 (actual)
- First posted
- 18 Jul 2008 (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 is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized (1:1), open-label, parallel-group study. Arm A received palifosfamide 150 mg/m² IV on Days 1 to 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles, and could then continue single-agent palifosfamide. Arm B received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants in Arm B whose disease progressed at or before Cycle 6 could choose to switch to single-agent palifosfamide; this was optional and not a planned crossover.
| Arm | Type | Receives |
|---|---|---|
| Palifosfamide-Tris Plus Doxorubicin | Experimental | Drug: Palifosfamide-Tris, Drug: DoxorubicinParticipants received palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 plus doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Doxorubicin was administered approximately 60 minutes after completion of the Day 1 palifosfamide-tris infusion. Participants could continue single-agent palifosfamide-tris after completion of combination treatment. |
| Doxorubicin Alone With Optional Palifosfamide-Tris After Progression | Active comparator | Drug: Palifosfamide-Tris, Drug: DoxorubicinParticipants received doxorubicin 75 mg/m² IV on Day 1 of each 21-day cycle for up to 6 cycles. Participants whose disease progressed at or before Cycle 6 could elect to receive single-agent palifosfamide-tris after disease progression. This treatment was optional and was not part of the randomized initial treatment assignment. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years
- Histological or cytological documentation of sarcoma (excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma) who have failed ≤2 prior regimens including adjuvant therapy, or ≤1 prior regimen for metastatic/unresectable disease, and for whom treatment with doxorubicin is considered medically acceptable. Prior treatment with IFOS is acceptable.
- Have measurable disease as per RECIST criteria (Appendix 2)
- ECOG Performance Status of 0 or 1 (Appendix 3)
- Anthracyclin naïve
Key exclusion criteria (20 listed)
- Has any one of the following sarcoma sub types: alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma, mixed mesodermal tumor, osteosarcoma, radiation induced sarcomas, and unresectable low grade liposarcoma.
- Clinically evident congestive heart failure >Class II of the New York Heart Association (NYHA) guidelines (Appendix 4)
- Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia, or ventricular arrhythmias classified as Lown III, IV, or V (Appendix 4)
- History and/or signs of active coronary artery disease/ischemia with or without angina pectoris
- Serious myocardial dysfunction defined as scintigraphically (MUGA [multiple gated acquisition scan], myocardial scintigram) or ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45%
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-TrisAlso: ZIO-201, isophosphoramide mustardPalifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle. | Drug | Doxorubicin Alone With Optional Palifosfamide-Tris After Progression, Palifosfamide-Tris Plus Doxorubicin |
| DoxorubicinAlso: AdriamycinDoxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for up to 6 cycles. | Drug | Doxorubicin Alone With Optional Palifosfamide-Tris After Progression, Palifosfamide-Tris Plus Doxorubicin |
Primary outcome
The primary efficacy analysis will be conducted on the intent-to-treat (ITT) population. All attempts will be made to conduct assessment of disease status every 6 weeks until progression of disease or initiating off protocol anti cancer therapies.
Time frame: Every 6 weeks until progression
Results and safety
The study was stopped early (reason given: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached. Enrolled participants were followed to their PFS endpoint.). Results are not available in the source record.
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 J Lewis, MD, PhD study director
ZIOPHARM Oncology, Inc
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palifosfamide-Tris and Doxorubicin in people with Soft Tissue Sarcoma, run by Alaunos Therapeutics at 23 sites in 3 countries.
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 17 inclusion and 20 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 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 23 sites in United States, Italy, Romania. 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?
The study was stopped early (reason given: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached. Enrolled participants were followed to their PFS endpoint.). Results are not available in the source record.
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?
The primary efficacy analysis will be conducted on the intent-to-treat (ITT) population. All attempts will be made to conduct assessment of disease status every 6 weeks until progression of disease or initiating off protocol anti cancer therapies. (time frame: Every 6 weeks until progression). 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.