A Pilot Study of Pentostatin Plus Cyclophosphamide Immune Depletion to Decrease Immunogenicity of SS1P in Patients With Mesothelioma
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Raffit Hassan, M.D.
Yvonne Mallory, R.N., B.S.N.
Jeannette Nashed, C.R.N.P.
Lisa Bengtson, R.N., M.S.N.
Key Eligibility Criteria:
- Histologically confirmed pleural or peritoneal epithelial or biphasic mesothelioma not amenable to potentially curative surgical resection (patients with biphasic tumors that have ≥ to 50 percent sarcomatoid component will be excluded)
- Has been treated with at least one platinum-containing chemotherapy regimen with progressive disease documented prior to study entry
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
- ≥ 18 years of age
- ECOG ≤ 1
- Adequate hematologic, renal, and hepatic function
- Able to swallow whole pills
- No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- No major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- The first cycle will last 38 days and subsequent cycles will last 25 days
- In each cycle participants receive:
- Participants may receive up to five further 25 day cycles
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment
- Follow-up visits every 3 months until disease progression
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.