Soft Tissue SarcomaPhase 1NCT00629343
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
A Phase 1 study testing Azacitidine and Temozolomide in people with Soft Tissue Sarcoma and Mesothelioma, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma, Mesothelioma
- What is being tested?
- Azacitidine and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2012
- Phase
- Phase 1
- 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
- Histologically confirmed soft tissue sarcoma or mesothelioma.
- Ineligible for other high priority national or institutional study.
- Non-pregnant, non-lactating.
- Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
- Measurable disease defined as lesions that can be measured in at least one dimension by physical examination or by means of medical imaging techniques. Ascites and pleural effusions will not be considered measurable disease.
- Prior chemotherapy is allowed with the exception of prior treatment with Temozolomide or Azacitidine. Patients must have received prior 1st line therapy. There is no upper limit to the number of prior therapies received. Prior treatment with an alkylating agent is acceptable.
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- Prior radiation therapy is allowed.
- At least 4 weeks since prior chemotherapy or at least 6 weeks since prior radiation therapy.
- Patients may have had another cancer but there must be convincing clinical evidence that the sarcoma is the disease requiring therapeutic intervention. (i.e. Several sarcoma patients have had had a prior cancer [Hodgkin's disease or breast cancer] treated years previously and then developed a clinically active sarcoma.)
- Clinical parameters: Life expectancy > 3 months, Age > 18 years, Performance Karnofsky performance status of greater than or equal to 60%.
- Required initial laboratory data:
- Absolute neutrophil count > 1,500/mm3
- Hemoglobin > 10.0 g/dl
- Platelet count > 100,000/mm3
- Total Bilirubin < 1.5 times upper limit of normal (ULN) for the laboratory.
- Transaminases: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels must be < 2 x ULN. If there is known hepatic metastasis, transaminases may be < 5 times upper limit of normal.
- Serum creatinine levels < 1.5 x ULN.
- Women of child-bearing potential must have a negative serum pregnancy test prior to initiation of treatment.
- Men and women of child-bearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter (approximately 3 months).
- Capable of providing written, informed consent. Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection).
- No uncontrolled central nervous system metastases.
Who cannot join
- Known or suspected hypersensitivity to azacitidine or mannitol
- Pregnant or breast-feeding
- Histology other than soft-tissue sarcoma or mesothelioma
- Active or uncontrolled infection or other serious systemic disease
- Prior treatment with temozolomide or azacitidine
- Pregnant or lactating women
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- Uncontrolled central nervous system metastases
- Liver metastases
- Patients will not be excluded if they do not wish to participate in the second biopsy for tissue evaluation
- Subjects who have not had prior chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
Read the detailed description
The primary objective of the study is to determine the clinical and laboratory toxicities as well as acceptability/tolerance of this dose schedule of combined drug treatment with temozolomide and azacitidine.
Secondary objectives include determination of biochemical response to azacitidine as defined as change in methylation status. The investigators will specifically be looking at changes in genome wide methylation patterns as determined by two high-throughput platforms:
- A single nucleotide polymorphism chip-based method (MSNP) for genome wide epigenetic profiling
- CpG island promoter arrays will be performed to focus on promoter methylation status.
The investigators will also monitor clinical response, time to progression and overall survival.
- Conditions
- Soft Tissue Sarcoma, Mesothelioma
- Being tested
- Azacitidine, Temozolomide
- Keywords
- Soft Tissue Sarcoma, Mesothelioma, Azacitidine, Temozolomide, Temodar
- Medical subject headings
- Sarcoma, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called Vidaza
Azacitidine will be delivered sub-cutaneously for 5 days
TemozolomideDrug
Also called Temodar
Temozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will receive azacitidine in combination with temozolomide Receives: Drug: Azacitidine; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose of Temozolomide
Maximum tolerated dose of temozolomide when used in combination with azacitidine
Measured: Up to 26 weeks for each dosing cohort
Maximum Tolerated Dose of Azacitidine
Maximum tolerated dose of azacitidine when used in combination with temozolomide
Measured: Up to 26 weeks for each dosing cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Robert N Taub, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629343
- Sponsor's protocol ID
- AAAC3255
- Status last verified
- May 2025
- First submitted
- 26 Feb 2008
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide In Patients With Unresectable Or Metastatic Soft Tissue Sarcoma or Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT00629343
- Acronym / sponsor ID
- AAAC3255
- Conditions
- Soft Tissue Sarcoma, Mesothelioma
- Keywords
- Soft Tissue Sarcoma, Mesothelioma, Azacitidine, Temozolomide, Temodar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Schering-Plough, Celgene Corporation
- Study start
- Oct 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine safety and toxicity for the combination of Temozolomide and Azacitidine in the treatment of Advanced Soft Tissue Sarcoma or Malignant Mesothelioma. This is a single-center, open-label, single-arm Phase I dose-escalation trial. Patients will be evaluated with complete history and physical as well as laboratory studies (complete blood count, metabolic panel, liver function tests), biopsy, and imaging of all sites of measurable disease. This study will be conducted over the course of 3 years.
Detailed description
The primary objective of the study is to determine the clinical and laboratory toxicities as well as acceptability/tolerance of this dose schedule of combined drug treatment with temozolomide and azacitidine.
Secondary objectives include determination of biochemical response to azacitidine as defined as change in methylation status. The investigators will specifically be looking at changes in genome wide methylation patterns as determined by two high-throughput platforms:
- A single nucleotide polymorphism chip-based method (MSNP) for genome wide epigenetic profiling
- CpG island promoter arrays will be performed to focus on promoter methylation status.
The investigators will also monitor clinical response, time to progression and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Azacitidine, Drug: TemozolomideSubjects will receive azacitidine in combination with temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically confirmed soft tissue sarcoma or mesothelioma.
- Ineligible for other high priority national or institutional study.
- Non-pregnant, non-lactating.
- Recurrent or progressive disease defined as an increase in size of any existing tumor mass, or the development of new tumor mass or masses, which is not amenable to definitive surgical therapy.
- Measurable disease defined as lesions that can be measured in at least one dimension by physical examination or by means of medical imaging techniques. Ascites and pleural effusions will not be considered measurable disease.
Key exclusion criteria (10 listed)
- Known or suspected hypersensitivity to azacitidine or mannitol
- Pregnant or breast-feeding
- Histology other than soft-tissue sarcoma or mesothelioma
- Active or uncontrolled infection or other serious systemic disease
- Prior treatment with temozolomide or azacitidine
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 |
|---|---|---|
| AzacitidineAlso: VidazaAzacitidine will be delivered sub-cutaneously for 5 days | Drug | Treatment |
| TemozolomideAlso: TemodarTemozolomide will be given starting on day 8 for 5 days at a dose of 200 mg/m2 po qd x 5 days | Drug | Treatment |
Primary outcome
Maximum Tolerated Dose of Temozolomide
Time frame: Up to 26 weeks for each dosing cohort
Maximum tolerated dose of temozolomide when used in combination with azacitidine
Maximum Tolerated Dose of Azacitidine
Time frame: Up to 26 weeks for each dosing cohort
Maximum tolerated dose of azacitidine when used in combination with temozolomide
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Robert N Taub, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azacitidine and Temozolomide in people with Soft Tissue Sarcoma and Mesothelioma, run by Columbia University at 1 site 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 22 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 5 Jun 2025). 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?
Maximum Tolerated Dose of Temozolomide (time frame: Up to 26 weeks for each dosing cohort). The study lists 2 primary outcomes in all. 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 Jun 2025.