Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide (NCT00629343) | Clinical Trial Compass
CompletedPhase 1
Phase I Dose-Escalation Study Of Azacitidine In Combination With Temozolomide
United States27 participantsStarted 2007-10
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* 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…