Phase I/II Trial Investigating The Safety And Immunogenicity Of Adenoviruses Encoding The Melan-A/MART-1 And gp 100 Melanoma Antigens Administered Intradermally To Patients With Stage II-IV Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Phase I/II Trial Investigating The Safety And Immunogenicity Of Adenoviruses Encoding The Melan-A/MART-1 And gp 100 Melanoma Antigens Administered Intradermally To Patients With Stage II-IV Melanoma
OBJECTIVES: I. Determine the safety and the maximum tolerated dose of vaccines containing
two adenoviral vectors encoding the melanoma antigens Melan-A/MART-1 and gp100 in patients
with stage II-IV melanoma. II. Assess the dose-response changes in the frequency of MART-1
and gp100 reactive T cells (CD4+ and CD8+) in patients receiving one of three different
vaccine regimens. III. Assess the T-cell response to one melanoma antigen following three
treatments with the other antigen in these patients. IV. Assess the effect of concomitant
vaccination with both antigens on T-cell response in these patients.
OUTLINE: This is a dose escalation study. Patients are sequentially enrolled on 1 of 3
treatment arms. Each treatment arm has 3 groups. Arm I: Patients receive Ad2/MART-1v2
vaccine and Ad2/gp100v2 vaccine intradermally (ID) at the lowest dose level once every three
weeks for either 6 or 15 weeks depending on assignment. Arm II: Patients receive Ad2/gp100v2
vaccine and Ad2/MART-1v2 vaccine ID at the mid-range dose level once every three weeks for
either 6 or 15 weeks depending on assignment. Arm III: Patients receive Ad2/MART-1v2 vaccine
and Ad2/gp100v2 vaccine ID at the highest dose level once every three weeks for either 6 or
15 weeks depending on assignment. Cohorts of 3-6 patients receive escalating doses of
Ad2/MART-1v2 and/or Ad2/gp100v2 vaccines in each arm until the maximum tolerated dose (MTD)
is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. Patients are followed at 3 months, 6 months, and 1 year
after completion of treatment.
PROJECTED ACCRUAL: A total of 24-36 patients will be accrued over 1 year.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage II, III, or IV cutaneous malignant
melanoma No evidence of disease at time of entry to protocol Definitive complete surgical
resection within past 12 months HLA-A2 positive
PATIENT CHARACTERISTICS: Age: 18 or over Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000 cells/mm3 Platelet count at least 100,000
cells/mm3 No clinically significant hematologic disease that would preclude study Hepatic:
SGOT and SGPT less than 2 times upper limit of normal Bilirubin less than 2 mg/dL No
clinically significant hepatic disease that would preclude study Renal: Creatinine less
than 2 mg/dL No clinically significant renal disease that would preclude study
Cardiovascular: No clinically significant cardiac disease that would preclude study Other:
No clinically significant underlying condition that would preclude study No significant
autoimmune disease or other major immune system disorder HIV negative HTLV negative
Hepatitis B and C negative No active infection requiring parenteral antibiotics No
psychiatric disorder that could hinder protocol compliance Not pregnant or nursing Fertile
patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy At least
3 months since prior interferon therapy Chemotherapy: No prior or concurrent chemotherapy
Endocrine therapy: No prior or concurrent immunosuppressants Radiotherapy: At least 4
weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery Other: No
other prior or concurrent experimental anticancer therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Amy E. Bock
Investigator Role:
Study Chair
Investigator Affiliation:
Genzyme
Authority:
United States: Federal Government
Study ID:
CDR0000068478
NCT ID:
NCT00010309
Start Date:
November 2000
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| U.S. Oncology | Houston, Texas 77060 |
| Genzyme Corporation | Cambridge, Massachusetts 02139-1562 |
