Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine
An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected Stage II and III (N1a, N2a) Melanoma
2 other identifiers
interventional
38
1 country
1
Brief Summary
The goal of this clinical research study is to find the best dosing schedule of a combined treatment of PEG Intron® (pegylated Interferon-alfa 2b) plus a peptide vaccine (gp100) that may help improve immune response in patients that had Stage II or Stage III melanoma and are free of the disease. The safety and tolerability of this drug combination will also be studied. Researchers also want to collect long-term follow-up information.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2009
CompletedFirst Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2017
CompletedMarch 3, 2017
February 1, 2017
8 years
March 12, 2009
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Maximum T-cell Levels During 24-Week Treatment
Patient's T-cell levels assessed every 3 weeks using a tetramer assay.
Study Arms (3)
Group 1
EXPERIMENTALPegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide
Group 2
EXPERIMENTALPegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide
Group 3
EXPERIMENTALPegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide
Interventions
Group 1: 6 mcg/kg by injection under skin once weekly for 4 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 20 weeks. Group 2: 6 mcg/kg by injection under skin once weekly for 8 weeks, followed by Maintenance Phase of 3 mcg/kg weekly for 16 weeks. Group 3: 6 mcg/kg by injection under skin once weekly for 12 weeks followed by Maintenance Phase of 3 mcg/kg weekly for 12 weeks.
Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Eligibility Criteria
You may qualify if:
- Patients must be free of disease after surgical resection for American Joint Committee on Cancer (AJCC) stage II or III (N1a) melanoma (T2b, T3a, T3b, T4a, T4b and N1a or N2a). Diagnosis must be confirmed by the Pathology Department of MD Anderson Cancer Center.
- Patients must be HLA-A0201 positive.
- Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery and before study entry.
- Patients must have no other 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 skin cancer are eligible. Patients with other malignancies are eligible, if they have been continuously disease-free for 5 years prior to the time of study entry.
- Patients must be \>/= 18 years of age.
- Patients must give signed written informed consent.
- Women of childbearing potential (WOCBP) must not be pregnant (negative urine human chorionic gonadotropin (HCG) within 2 weeks of treatment) or lactating. A WOCBP has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., 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. Simultaneous use of two contraceptive methods such as, intrauterine device (IUD) or condom and contraceptive jelly is considered the accepted method of contraception.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have white blood cell count (WBC) \>/= 3,000/mm3, platelet count \>/= 100,000/mm3, and hemoglobin \>/= 9 g/dL or 5.6 mmole/L obtained within 2 weeks of study entry.
- Patients must have AST, ALT, LDH, alkaline phosphatase, and bilirubin within institutional upper limit (IUL) of normal and serum creatinine \< 2.0 mg/dl or \< 140 micromol/L all obtained within 2 weeks of study entry. Patients with Gilbert's Disease may have bilirubin \</= to 2 x (ULN).
- Patients must have a CT of chest, abdomen, pelvis, and a MRI or CT scan of the brain performed within 4 weeks of study entry.
You may not qualify if:
- Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease.
- Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate.
- Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs.
- 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 have 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. Any questionable patients will be reviewed by the investigator or attending physician.
- Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer.
- Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy.
- Patients with any other significant medical or surgical condition or psychiatric disorder, which includes any serious psychiatric illness that has not been adequately controlled despite intervention (with our without medication) with known history of HIV or hepatitis infection may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study compound.
- Patients with thyroid dysfunction not responsive to therapy.
- Patients with pre-existing psychiatric condition including, but not limited to: a. History of severe depression, including the following: 1) Hospitalization for depression 2) Electroconvulsive therapy for depression 3) Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions. b. Suicidal or homicidal ideation and/or suicidal or homicidal attempt. c. History of severe psychiatric disorders (eg. psychosis, post-traumatic stress disorder or mania). d. Past history or current use of lithium and/or antipsychotic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Jen Hwu, MD, PhD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
March 10, 2009
Primary Completion
February 24, 2017
Study Completion
February 24, 2017
Last Updated
March 3, 2017
Record last verified: 2017-02