Decitabine With or Without Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Solid Tumors

Stopped early · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects of decitabine when given together with or without interferon alfa-2b, and the best dose of interferon alfa-2b, in treating patients with unresectable or metastatic solid tumors. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as interferon alfa-2b, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether decitabine is more effective when given with or without interferon alfa-2b in treating solid tumors.

Key facts

Study ID

NCT00701298

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2009-04-01

Last updated by the study team

2014-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-proven solid tumor
• Metastatic or unresectable disease
• Tumor amenable to biopsy
• No curative or more effective treatment for this disease exists, in the opinion of the investigator
• Measurable disease by scans as assessed by RECIST criteria
• No untreated brain metastasis
• No longer receiving steroid therapy for previously treated brain metastasis
• Zubrod performance status of 0-2
• Bilirubin ≤ 1.5 times upper limit normal (ULN)
• SGOT or SGPT ≤ 2.5 times ULN (≤ 5 ULN if hepatic metastases present)
• Serum creatinine ≤ 1.5 times ULN
• Creatinine clearance ≥ 50 mL/min
• ANC > 1,500/μL
• Platelet count > 100,000/μL
• Hemoglobin > 9 g/dL (transfusion allowed)
• No NYHA class III-IV cardiac problems (e.g., congestive heart failure or myocardial infarction within the past 2 months)
• No severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection [e.g., HIV])
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy
• Willing to undergo biopsies
• No medical or psychological conditions that, in the opinion of the investigator, may preclude the patient's ability to tolerate or complete the treatment, or to grant reliable informed consent
• No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I, II, or III cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• No prior extensive pelvic irradiation or prolonged nucleoside analogue pretreatment
• At least 28 days since prior and no concurrent chemotherapy, radiotherapy, surgery, biological therapy, anticancer agent, or other investigational drug

Where it is running

• Nevada Cancer Institute-Summerlin Campus — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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