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Phase II Randomized Adjuvant Study of Vaccination With Tyrosinase, gp100, and MART-1 Peptides Emulsified With Montanide ISA-51 With Interleukin-12 and Either Alum Adjuvant or Sargramostim (GM-CSF) in Patients With Resected Stage IIB, IIC, III, or IV Melanoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI
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LAC-USC-10M011 LAC-USC-IRB-013030, NCI-5506, NCT00031733, 5506
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Objectives - Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).
Entry Criteria Disease Characteristics:
- Diagnosis of stage IIB, IIC, III, or IV cutaneous melanoma OR stage III
or IV
ocular or mucosal melanoma
- Resected or rendered disease-free
- HLA-A2.1-positive by standard cytotoxicity assay
- Tumor tissue must be available for analysis of gp100 staining and
tyrosinase
and MART-1 expression by immunohistochemistry
- Must be positive for at least 1 antigen
- Failed, ineligible for, or refused prior interferon alfa
Prior/Concurrent Therapy:
Biologic therapy: - See Disease Characteristics
- No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or
MART-1:26-35 (27L) peptides
Chemotherapy: - At least 1 month since prior adjuvant chemotherapy for this
disease
- No concurrent adjuvant chemotherapy
Endocrine therapy: Radiotherapy: - At least 1 month since prior radiotherapy for this
disease
- No concurrent radiotherapy
Surgery: - See Disease Characteristics
Other: - At least 1 month since other prior therapy, including adjuvant
therapy, for this disease
- No other concurrent therapy, including adjuvant
therapy
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 3,000/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9.0 g/dL
- No bleeding disorder
Hepatic: - Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2.5 times normal
- No coagulation disorder
- Hepatitis surface antigen B negative
- Hepatitis C negative
Renal: - Creatinine no greater than 2.0 mg/dL
Cardiovascular: - No major cardiovascular illness
Pulmonary: - No major respiratory illness
Immunologic: - No prior uveitis
- No prior autoimmune inflammatory eye disease
- No immune hemolytic anemia
- No other active autoimmune disease
Other: - HIV negative
- No major gastrointestinal illness
- No other malignancy within the past 5 years except squamous
cell skin cancer or carcinoma in situ of the cervix curatively treated at
least 30 days ago
- No major systemic infection (e.g., pneumonia or
sepsis)
- No other major medical illness
- No prior allergic reaction to Montanide ISA-51 or alum
adjuvant
- No requirement for steroid therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment A total of 60 patients (20 per treatment arm) will be accrued for this study
within 3 years. Outline This is a randomized study. Patients are stratified according to
disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal
stage III and IV). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients receive vaccine with tyrosinase:368-376
(370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with
Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously
(SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and
53.
- Arm II: Patients receive peptide vaccine emulsified with ISA-51,
high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15,
19, 27, and 53.
- Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day
1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1,
3, 5, 7, 11, 15, 19, 27, and 53.
Patients are followed every 3 months for 2 years, every 6 months for 3
years, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations USC/Norris Comprehensive Cancer Center and Hospital | | | Jeffrey Weber, MD, PhD, Protocol chair(Contact information may not be current) | | | |
Registry Information | | Official Title | | A Phase II Randomized Trial of a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified with Montanide ISA 51 with Interleukin-12 with Alum or GM-CSF for Patients with Resected Stages IIB/C, III and IV Melanoma | | Trial Start Date | | 2002-02-27 | | Registered in ClinicalTrials.gov | | NCT00031733 | | Date Submitted to PDQ | | 2002-01-09 | | Information Last Verified | | 2005-02-24 | | NCI Grant/Contract Number | | CA14089, CA90751 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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