Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00010309
First received: February 2, 2001
Last updated: January 3, 2014
Last verified: July 2002

February 2, 2001
January 3, 2014
November 2000
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Complete list of historical versions of study NCT00010309 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
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

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage II, stage III, or stage 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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: MART-1 antigen
  • Biological: gp100 antigen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010309
CDR0000068478, GENZ-ADVMEL-001-99, DFCI-00069, GENZ-2000-P-000380/1
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Genzyme, a Sanofi Company
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Study Chair: Amy E. Bock Genzyme, a Sanofi Company
National Cancer Institute (NCI)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP