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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity based on CTCAE Version 3.0

Outcome Time Frame:

Daily for 10 days out of 14, and then weekly every 28 days

Safety Issue:

Yes

Principal Investigator

Wolfram Samlowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Nevada Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

NVCI-0725

NCT ID:

NCT00886457

Start Date:

April 2009

Completion Date:

October 2010

Related Keywords:

  • Cancer
  • Biopsy proven cancer, which is metastatic or unresectable

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135