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

NCT00791271 | Terminated Phase 1 DMC

• 2 other identifiers: 2007-0450NCI-2010-01030
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Malignant melanoma; Unresectable; Decitabine; PEG Interferon Alpha-2b; PEG Intron; 5-Aza-Deoxycytidine; Dacogen

Outcome Measures

Primary Outcomes (1)

• Phase I: Dose-limiting toxicity (DLT)

  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.

  4 weeks

Secondary Outcomes (1)

• Phase II: Patient Response

  12 weeks

Study Arms (1)

Decitabine + Peginterferon Alfa-2b

EXPERIMENTAL

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; Drug: Pegylated Interferon Alpha-2b

Interventions

Decitabine DRUG

Starting dose of 10mg/m\^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.

Also known as: 5-Aza-Deoxycytidine, Dacogen

Decitabine + Peginterferon Alfa-2b

Pegylated Interferon Alpha-2b DRUG

Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.

Also known as: PEG Interferon Alpha-2b, PEG Intron

Decitabine + Peginterferon Alfa-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically confirmed malignant melanoma that is unresectable stage III or stage IV.
• Patients must have measurable disease as defined by RECIST criteria.
• No more than two prior chemotherapy for unresectable stage III or IV melanoma.
• 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.
• 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.
• Patients must be \>/= 18 years of age.
• 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.
• 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.
• 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.
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 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)
• Patients with any number of prior targeted or cytokine therapies, but no more than two chemotherapy containing regimens.

You may not qualify if:

• 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.
• Patients who have previously received adjuvant high dose interferon.
• 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.
• 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 2 weeks prior to entering the study.
• Patients with brain metastases.
• 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.
• Patients with myocardial ischemia (MI), stroke, or transient ischemic attack (TIA) within the last 6 months.
• 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.
• Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired peripheral neuropathy.
• 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.
• Patients with thyroid dysfunction not responsive to therapy.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Schering-Plough: collaborator
• Eisai Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Melanoma

Interventions

Decitabine; peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Wen-Jen Hwu, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 14, 2008
• Study Start: September 2, 2008
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 9, 2018

Record last verified: 2018-11

Locations

US (1)