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5-aza-2-deoxycytidine With Pegylated Interferon-alfa 2B: A Phase I Study With Molecular Correlates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00886457
Recruitment Status : Terminated (low accrual)
First Posted : April 23, 2009
Last Update Posted : July 20, 2011
National Institutes of Health (NIH)
Information provided by:
Nevada Cancer Institute

Brief Summary:
The purpose of this study is to assess toxicities of a 1-hr infusion of 5-aza-2'-deoxycytidine (decitabine) x 10 days (M-F) plus escalating doses of weekly subcutaneous PEG-interferon-α (PEG-Intron) in patients with metastatic cancer and to identify the maximum tolerated dose of PEG-Intron in this combination. The pre- and post-treatment samples will be evaluated to identify changes in molecular correlates.

Condition or disease Intervention/treatment Phase
Cancer Drug: Decitabine and Pegylated Interferon-Alfa 2B Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhibition of DNA Methylation by 1-hr Infusion of 5-aza-2'-Deoxycytidine (Decitabine) x 10 Days (M-F) With Escalating Doses of Sub-Q Pegylated (PEG) Interferon-alfa 2B (PEG-Intron): A Phase I Study With Molecular Correlates
Study Start Date : April 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Decitabine plus PEG Interferon-alfa 2B
3.7 mg/m**2 decitabine plus 0, 0.5, 1.5, 3, or 6 mcg/kg PET-Intron
Drug: Decitabine and Pegylated Interferon-Alfa 2B
Patients will receive decitabine 3.7 mg/m2/day i.v. over 1 hour daily in 10 doses over 2 weeks elapsed time (Monday-Friday) every 28 days plus fixed dose of PEG-Intron (0, 0.5, 1.5, 3 or 6 mcg/kg PEG-Intron) weekly by subcutaneous injection in 28-day cycles .

Primary Outcome Measures :
  1. Dose limiting toxicity based on CTCAE Version 3.0 [ Time Frame: Daily for 10 days out of 14, and then weekly every 28 days ]

Secondary Outcome Measures :
  1. Genomic DNA methylation and Mage-1 specific promoter methylation in blood cells, tumor and skin [ Time Frame: Pretreatment, and then on days 8, 15, 22, and 29 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient must have a biopsy proven cancer, which is metastatic or unresectable, for which (in the opinion of the investigator), no curative or more effective treatment exists.
  2. Patient must have biopsy accessible tumor and must indicate willingness to undergo biopsies of tumor and normal skin on days 1, 15 and 29.
  3. Patient must have measurable disease by RECIST criteria by scans performed within 28 days of study enrollment.
  4. Patient may not have untreated brain metastasis. Patients with previously treated brain metastasis must no longer be receiving steroid therapy for the treatment of their brain metastasis.
  5. Patient must have a Zubrod performance status of 0 - 2.
  6. Prior surgery, radiotherapy or chemotherapy is allowed. The patient must not have received chemotherapy, radiotherapy, surgery, biologic therapy or any other investigational drug for any reason within 28 days prior to registration. Concomitant treatment with other anti-cancer agents or radiotherapy, including investigational agents during the course of study treatment is not allowed.
  7. Patients with extensive pelvic irradiation or prolonged nucleoside analogue pretreatment are excluded due to increased risk for hematologic toxicity.
  8. Patient must have adequate liver function as defined by a serum bilirubin ≤ 1.5 x the institutional upper limit of normal (IULN), SGOT or SGPT ≤ 2.5 x the institutional upper limit of normal (or ≤ 5 x the institutional upper limit of normal if hepatic metastases is present) obtained within 14 days prior to registration.
  9. Patient must have an adequate renal function as defined by a serum creatinine ≤ 1.5 x the institutional upper limit of normal, as well as a calculated or measured creatinine clearance (CrCl) ≥ 50 ml/min.
  10. Patient must have an ANC > 1,500/μl, platelet count > 100,000/μl and hemoglobin > 9 gm/dl (this may be achieved by transfusion if needed) obtained within 14 days prior to registration.
  11. All patients must be informed of the investigational nature of this study and must provide written acknowledgment of informed consent in accordance with institutional and federal guidelines.
  12. Both men and women of all races and ethnic groups are eligible for this trial.
  13. Patients must be ≥ 18 years of age.

Exclusion Criteria:

  1. Class 3/4 cardiac problems as defined by the New York Heart Association Criteria (e.g., congestive heart failure, myocardial infarction within 2 months of study).
  2. Severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled infection, e.g., HIV).
  3. Patient must not be pregnant or nursing mothers because PEG-Intron or decitabine may be harmful to the developing fetus and newborn. Women/men of reproductive potential must agree to use an effective contraceptive method. Women of reproductive potential must have a negative serum pregnancy test within 7 days prior to registration. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
  4. Medical or psychological conditions that, in the opinion of the investigator, make the patient unable to tolerate or complete the treatment, or to grant reliable informed consent are not eligible for this study.
  5. No other prior malignancy is allowed except for the following: 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00886457

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United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
Sponsors and Collaborators
Nevada Cancer Institute
National Institutes of Health (NIH)
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Principal Investigator: Wolfram Samlowski, MD Nevada Cancer Institute
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Responsible Party: Wolfram Samlowski, MD, Nevada Cancer Institute Identifier: NCT00886457    
Other Study ID Numbers: NVCI-0725
NCI 8224
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011
Keywords provided by Nevada Cancer Institute:
Biopsy proven cancer, which is metastatic or unresectable
Additional relevant MeSH terms:
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Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors