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Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma


Decitabine is designed to slow tumor growth and may cause death of cancer cells.

Interferon alfa-2B is designed to activate your immune system, which may help keep tumors
from growing, and may shrink tumors.


If you are found to be eligible to take part in this study, you will receive decitabine by
vein over 1 hour on Days 1-5 of each cycle. A cycle in this study is 28 days long. All
treatments with decitabine will take place at M. D. Anderson.

Once you have completed 2 cycles of decitabine (on Day 1 of Cycle 3), you will begin taking
interferon alfa-2b twice each day (morning and afternoon) while continuing the same 5-day
dosing schedule for decitabine. Interferon alfa-2b will be given as a subcutaneous (just
under the skin) injection. It can be given by yourself or a caregiver at home or by your
local doctor. You and your caregiver will be taught how to do the injection.


You will have the following tests/procedures performed during clinic visits.

On Day 1 of each cycle:

- You will have a physical exam, including measurement of your vital signs and weight.

- You will be asked about any medications or treatments you may be currently receiving.

- You will have a performance status evaluation.

- You will be asked about any side effects you may have experienced since your last
visit. You will have blood drawn (about 1 teaspoon) for routine testing.

Beginning in Cycle 3, you will be required to return to the clinic around Day 14 of each
cycle to have the following tests:

- You will have blood drawn (about 1 teaspoon each time) once a week for routine tests.
If you do not experience severe side effects during Cycles 3 and 4, you will no longer
be required to have weekly routine blood testing. Instead, you will return to have
routine blood drawn on Day 1 of each cycle. This once-weekly schedule will restart if
you experience severe side effects in Cycle 5.

- You will have a CT or MRI scan to check the status of the disease.

- Your vital signs will be measured

- You will be asked about any side effects you may have experienced since your last


You will continue taking the study drug combination unless the disease gets worse, you
develop an illness that does not allow you to continue receiving the study therapy, or you
experience any intolerable side effects. If any of these things occur, you will be removed
from this study.

This is an investigational study. Decitabine is FDA approved and commercially available for
the treatment of myelodysplastic syndrome (MDS). Interferon alfa-2b is FDA approved and
commercially available for the treatment of several types of cancer, such as malignant
melanoma, hairy cell leukemia, and non-Hodgkin's lymphoma. Their use together in this study
in the treatment of PRC is investigational and authorized for use in research only.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

- Patients must have histologically confirmed clear cell renal carcinoma that is
metastatic or unresectable. In the absence of metastatic disease, patients who are
deemed unresectable or inoperable will have a documented surgical opinion confirming
this. Surgical opinion will be rendered either by surgical consultation or after
presentation at our interdisciplinary conference. Patients with locally recurrent RCC
are eligible, if surgical resection of local recurrence is not feasible or is refused
by patient.

- Patients with locally advanced unresectable RCC should have measurable or evaluable
metastatic disease to be eligible for the protocol. Patients with bilateral renal
cancer are eligible as long as both cancers are of clear cell type and patients have
metastatic or unresectable disease.

- Patients may have received up to two prior anti-cancer therapies (including receptor
tyrosine kinase inhibitors or cytokine therapy) but no prior chemotherapy for renal
cell carcinoma. Patients should have received prior standard therapy, or otherwise
deemed ineligible for such therapies.

- Patients must have measurable or clinically evaluable disease as defined by RECIST

- Patients must be >/= 14 days beyond the last administration of anti-cancer therapy,
and must have recovered from the toxicities of prior therapy.

- Patients must be >/= 18 years of age.

- ECOG performance status /= 60%).

- Patients must have adequate organ and marrow function, measured within 14 days of
study entry, as defined below:

- All Patients: Absolute neutrophil count >/= 1,500/microL; Platelets >/=
100,000/microL; Creatinine (serum)
- Patients without liver metastases: Total bilirubin AST(SGOT)/ALT(SGPT)
- Patients with liver metastases: Total bilirubin AST(SGOT)/ALT(SGPT)
- The effects of decitabine and interferon on the developing human fetus are unknown.
For this reason and because chemotherapy agents are known to be teratogenic, women of
child-bearing potential and men must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while participating in this study, she should inform her treating physician

- Female patients of childbearing potential should have a normal plasma beta human
chorionic gonadotropin (betaHCG).

- Patients must give written informed consent prior to initiation of therapy in keeping
with the policies of the institution. Patients with a history of major psychiatric
illness must be judged able to fully understand the investigational nature of this
study and the risks associated with the therapy.

Exclusion Criteria:

- Patients with active autoimmune disorders or who are receiving immunosuppressive
therapy (including steroids or methotrexate) for any indication.

- Patients may not receive any other investigational agents within two weeks of study
entry. Patients may not receive any other investigational agents while on study.

- Patients who have had major surgery within 2 weeks prior to entering the study, or
have otherwise not adequately recovered from prior surgery.

- Patients who have had palliative radiation therapy within 1 week prior to entering
the study.

- Patients with untreated or symptomatic brain metastases.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, or
potentially life-threatening cardiac arrhythmia.

- Psychiatric illness or social situations which in the opinion of the investigator
could interfere with the completion of the proposed treatment.

- Pregnant women are excluded from this study because decitabine is an antimetabolite
with the potential for teratogenic or abortifacient effects and interferon alfa-2b
has abortifacient activity in animal studies. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with decitabine, breastfeeding should be discontinued if the mother is treated
with decitabine or decitabine and interferon.

- Because patients with immune deficiency are at increased risk of lethal infections
when treated with marrow-suppressive therapy, patients known to be HIV-positive and
receiving anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with the study agents.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS) Times

Outcome Description:

Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.

Outcome Time Frame:

From treatment start or until disease progression or death for any reason, at least 16 weeks

Safety Issue:


Principal Investigator

Ana M. Aparicio, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

November 2009

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Renal Cell Cancer
  • Clear Cell
  • Kidney
  • Decitabine
  • Dacogen
  • 5-Aza-Deoxycytidine
  • Interferon Alfa-2b
  • Intron A®
  • RCC
  • Carcinoma
  • Carcinoma, Renal Cell



UT MD Anderson Cancer Center Houston, Texas  77030