Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
|ClinicalTrials.gov Identifier: NCT00010309|
Recruitment Status : Unknown
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 11, 2003
Last Update Posted : January 6, 2014
|First Submitted Date ICMJE||February 2, 2001|
|First Posted Date ICMJE||November 11, 2003|
|Last Update Posted Date||January 6, 2014|
|Start Date ICMJE||November 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00010309 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Melanoma (Skin)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00010309|
|Other Study ID Numbers ICMJE||CDR0000068478
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Genzyme, a Sanofi Company|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Cancer Institute (NCI)|
|Verification Date||July 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP