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Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00561912
First received: November 20, 2007
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

Primary Objective:

  • To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.

Secondary Objectives:

  • To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in patients with advanced RCC
  • To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
  • To determine the overall survival times for patients with advanced RCC treated with decitabine and interferon.
  • To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.
  • To characterize the modulation of cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these results with clinical outcomes.

Condition Intervention Phase
Renal Cell Carcinoma
Drug: Decitabine
Drug: Interferon Alfa-2b
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival (PFS) Times [ Time Frame: From treatment start or until disease progression or death for any reason, at least 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: October 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Decitabine + Interferon Alfa-2b
Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
Drug: Decitabine
15 mg/m^2 IV Daily over one hour for 5 days
Other Names:
  • 5-Aza-Deoxycytidine
  • Dacogen
Drug: Interferon Alfa-2b
0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.
Other Name: Intron A®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 criteria.
  • 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 </= 2 (Karnofsky >/= 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) </= 2.0 mg/dL
    • Patients without liver metastases: Total bilirubin </= 1.5 mg/dL; AST(SGOT)/ALT(SGPT) </= 2.5 X Institutional Upper Limit of Normal (IULN)
    • Patients with liver metastases: Total bilirubin </= 1.5 x IULN; AST(SGOT)/ALT(SGPT) </= 5 x IULN
  • 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 immediately.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561912

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Ana M. Aparicio, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00561912     History of Changes
Other Study ID Numbers: 2006-0962
Study First Received: November 20, 2007
Results First Received: November 22, 2011
Last Updated: November 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Renal Cell Carcinoma
Renal Cell Cancer
Clear Cell
Kidney
Decitabine
Dacogen
5-Aza-Deoxycytidine
Interferon Alfa-2b
Intron A®
RCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Azacitidine
Decitabine
Interferon-alpha
Interferons
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014