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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00010309
First Posted: November 11, 2003
Last Update Posted: January 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin) Biological: MART-1 antigen Biological: gp100 antigen Phase 1 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2000
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010309


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Genzyme Corporation
Cambridge, Massachusetts, United States, 02139-1562
United States, Texas
U.S. Oncology
Houston, Texas, United States, 77060
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Chair: Amy E. Bock Genzyme, a Sanofi Company
  More Information

ClinicalTrials.gov Identifier: NCT00010309     History of Changes
Other Study ID Numbers: CDR0000068478
GENZ-ADVMEL-001-99
DFCI-00069
GENZ-2000-P-000380/1
First Submitted: February 2, 2001
First Posted: November 11, 2003
Last Update Posted: January 6, 2014
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
stage II melanoma
stage III melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas