Adjuvant Therapy of Pegylated Interferon- 2b Plus Melanoma Peptide Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00861406
First received: March 12, 2009
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: Pegylated Interferon-Alfa 2b (PEG Intron)
Drug: GP-100 Peptide Vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Study of Adjuvant Therapy of Pegylated Interferon-Alfa 2b Plus Melanoma Peptide Vaccine in Patients With Resected, Intermediate-Thickness, Node-Negative Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Maximum T-cell Levels During 24-Week Treatment [ Time Frame: Patient's T-cell levels assessed every 3 weeks using a tetramer assay. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2009
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Pegylated Interferon alfa-2b (Once week x 4 weeks) + GP-100 Peptide
Drug: Pegylated Interferon-Alfa 2b (PEG Intron)

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.

Other Name: Peginterferon alfa-2b
Drug: GP-100 Peptide Vaccine
Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Other Names:
  • GP-100 Peptide Vaccine
  • melanoma peptide gp100 vaccine
Experimental: Group 2
Pegylated Interferon alfa-2b (Once week x 8 weeks) + GP-100 Peptide
Drug: Pegylated Interferon-Alfa 2b (PEG Intron)

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.

Other Name: Peginterferon alfa-2b
Drug: GP-100 Peptide Vaccine
Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Other Names:
  • GP-100 Peptide Vaccine
  • melanoma peptide gp100 vaccine
Experimental: Group 3
Pegylated Interferon alfa-2b (Once week x 12 weeks) + GP-100 Peptide
Drug: Pegylated Interferon-Alfa 2b (PEG Intron)

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.

Other Name: Peginterferon alfa-2b
Drug: GP-100 Peptide Vaccine
Injection under skin once every 3 weeks (Weeks 1, 4, 7, 10, 13, 16, 19, and 22), for a total of 8 injections.
Other Names:
  • GP-100 Peptide Vaccine
  • melanoma peptide gp100 vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients must be free of disease after surgical resection for 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.
  2. Patients must be HLA-A0201 positive.
  3. Patients must be fully recovered from surgery, for at least one month, but not more than 90 days after surgery and before study entry.
  4. 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.
  5. Patients must be >/= 18 years of age.
  6. Patients must give signed written informed consent.
  7. Women of childbearing potential (WOCBP) must not be pregnant (negative urine 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).
  8. 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, IUD or condom and contraceptive jelly is considered the accepted method of contraception.
  9. Patients must have ECOG performance status 0 or 1.
  10. Patients must have 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.
  11. 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).
  12. 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.

Exclusion Criteria:

  1. Patients with clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or any distant metastatic disease.
  2. Patients with autoimmune disorders or receiving immunosuppressive therapy including chemotherapy, steroids or methotrexate.
  3. Patients requiring consistent use of antihistamines or non-steroidal anti-inflammatory drugs.
  4. 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.
  5. 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.
  6. Patients having prior radiotherapy, chemotherapy or any immunotherapy including, tumor vaccines, interferon, interleukins, levamisole or other biologic response modifiers for any type of cancer.
  7. Patients with a history of CNS demyelinating, inflammatory disease or hereditary or acquired grade 2 or higher peripheral neuropathy.
  8. Patients with any other significant medical or surgical condition or psychiatric disorder, 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.
  9. Patients with thyroid dysfunction not responsive to therapy.
  10. 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.
  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: NCT00861406

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Wen-Jen Hwu, MD, PhD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00861406     History of Changes
Other Study ID Numbers: 2006-0816, NCI-2012-01652
Study First Received: March 12, 2009
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Melanoma
Stage II melanoma
Pegylated Interferon-alfa 2b
PEG Interferon alfa-2b
PEG Intron
Melanoma Peptide Vaccine
GP100 Vaccine
gp100
peptide vaccine
Leukapheresis
Immune-cell response

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferons
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2014