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Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion

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: NCT00791271
Recruitment Status : Terminated
First Posted : November 14, 2008
Last Update Posted : November 9, 2018
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied.

The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Decitabine Drug: Pegylated Interferon Alpha-2b Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma
Actual Study Start Date : September 2, 2008
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Decitabine + Peginterferon Alfa-2b
Decitabine starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. Peginterferon Alfa-2b starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
Drug: Decitabine
Starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.
Other Names:
  • 5-Aza-Deoxycytidine
  • Dacogen

Drug: Pegylated Interferon Alpha-2b
Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
Other Names:
  • PEG Interferon Alpha-2b
  • PEG Intron

Primary Outcome Measures :
  1. Phase I: Dose-limiting toxicity (DLT) [ Time Frame: 4 weeks ]

    Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria:

    Any grade 3 or 4 non-hematologic toxicity regardless of duration, except:

    1. Grade 3 nausea or vomiting occurring without maximal antiemetic therapy.
    2. Grade 3 diarrhea that occurs following without adequate loperamide therapy.

      • Grade 4 thrombocytopenia.
      • Grade 4 neutropenia lasting > 2 weeks or associated with infection.
      • Any toxicity that results in a treatment delay of > 4weeks.

Secondary Outcome Measures :
  1. Phase II: Patient Response [ Time Frame: 12 weeks ]
    Success defined as either a complete response (CR), a partial response (PR), or stable disease (SD). Target combined endpoint of CR+PR+SD in this trial is 30%. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.

Information from the National Library of Medicine

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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. Patients must have pathologically confirmed malignant melanoma that is unresectable stage III or stage IV.
  2. Patients must have measurable disease as defined by RECIST criteria.
  3. No more than two prior chemotherapy for unresectable stage III or IV melanoma.
  4. Patients must be >/= 28 days beyond the last administration of anticancer therapy, and must have recovered from the toxicities of prior therapy. If the patient was recently treated with a nitrosurea, they must be >/= 42 days beyond the last administration.
  5. Patients must have no other active malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible, if their disease has been inactive for 2 years prior to the time of study entry.
  6. Patients must be >/= 18 years of age.
  7. 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.
  8. Women of childbearing potential (WOCBP) must not be pregnant (negative urine human chorionic gonadotropin (HCG) within 2 weeks of treatment) or lactating. A WOCBP is defined as a woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
  9. Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 3 months after completing or discontinuing treatment.
  10. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  11. 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/uL - Platelets >/=100,000/uL - Creatinine (serum) </= 2.0 mg/dL - Total bilirubin </= 1.5 mg/dL - AST(SGOT)/ALT(SGPT) </= 2.5 X Institutional Upper Limit of Normal (IULN)
  12. Patients with any number of prior targeted or cytokine therapies, but no more than two chemotherapy containing regimens.

Exclusion Criteria:

  1. Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication are excluded. An exception may be made, by the PI, to include patients with adrenal insufficiency requiring physiologic steroid hormone replacement only.
  2. Patients who have previously received adjuvant high dose interferon.
  3. Patients may not receive any other investigational agents within four weeks of study entry. Patients may not receive any other investigational agents while on study.
  4. Patients who have had major surgery within 2 weeks prior to entering the study, or have otherwise not adequately recovered from prior surgery.
  5. Patients who have had palliative radiation therapy within 2 weeks prior to entering the study.
  6. Patients with brain metastases.
  7. Patients with a history of active ischemic heart disease or cerebro-vascular disease, congestive heart failure (NYHA class >2) or anginal syndrome requiring ongoing medical treatment.
  8. Patients with myocardial ischemia (MI), stroke, or transient ischemic attack (TIA) within the last 6 months.
  9. Patients with a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol.
  10. Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired peripheral neuropathy.
  11. Patients with known history of HIV and hepatitis infection or any other significant medical or surgical condition or psychiatric disorder that may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study combination.
  12. Patients with thyroid dysfunction not responsive to therapy.

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): NCT00791271

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
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Principal Investigator: Wen-Jen Hwu, MD, PhD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00791271    
Obsolete Identifiers: NCT02605473
Other Study ID Numbers: 2007-0450
NCI-2010-01030 ( Registry Identifier: NCI CTRP )
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Keywords provided by M.D. Anderson Cancer Center:
Malignant melanoma
PEG Interferon Alpha-2b
PEG Intron
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
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