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Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gp100 antigen
incomplete Freund's adjuvant
recombinant interleukin-12
tyrosinase peptide
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of gp100/tyrosinase expression Detectable expression of one or the other antigen not required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery

Sites / Locations

  • Beckman Research Institute, City of Hope
  • USC/Norris Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003339
Brief Title
Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma
Official Title
A Randomized Phase II Trial of a Vaccine Combining Tyrosinase/gp100 Peptides Emulsified With Montanide ISA 51 With and Without Interleukin-12 for Patients With Resected Stages III and IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
November 1999 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.
Detailed Description
OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma. OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy (immunotherapy or chemotherapy vs surgery only). Patients are randomized to receive 1 of 2 treatment arms: Arm I: Following surgery, patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Arm II: Following surgery, patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations. Patients are followed at 2-4 weeks, then every 3 months for 2 years after resection, then every 6 months for 3 years, and then yearly if without evidence of disease. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma, Melanoma (Skin)
Keywords
recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
gp100 antigen
Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Intervention Type
Biological
Intervention Name(s)
recombinant interleukin-12
Intervention Type
Biological
Intervention Name(s)
tyrosinase peptide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa HLA-A2 positive Tumor tissue must be available for analysis of gp100/tyrosinase expression Detectable expression of one or the other antigen not required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No major cardiovascular illness Pulmonary: No major respiratory illness (e.g., pneumonia) Gastrointestinal: No major gastrointestinal illness Other: Not pregnant or nursing No major systemic infection (e.g., sepsis) No coagulation or bleeding disorder HIV negative Hepatitis B surface antigen negative Hepatitis C surface antigen negative No history of uveitis or autoimmune inflammatory eye disease No active autoimmune disease Not allergic to Montanide ISA-51 No active second malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 1 month since prior biologic therapy Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy Endocrine therapy: At least 1 month since prior endocrine therapy No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics At least 1 month since prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Weber, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy With or Without Interleukin-12 in Treating Patients With Stage III or Stage IV Melanoma

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