Status:
TERMINATED
Decitabine With or Without Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. To assess toxicities of decitabine plus escalating doses of pegylated interferon alfa-2b (PEG-Intron) in patients with metastatic solid tumor. II. To identify the dose-limitin...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00701298
Start Date
April 1 2009
Last Update
February 24 2014
Active Locations (1)
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1
Nevada Cancer Institute-Summerlin Campus
Las Vegas, Nevada, United States, 89135