Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005052
First received: April 6, 2000
Last updated: February 6, 2009
Last verified: January 2006
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma.

PURPOSE: This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: GM2-KLH vaccine
Biological: QS21
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination: Post-Operative Adjuvant Ganglioside GM2-KLH/QS-21 (BMS-248479) Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 1.5mm (AJCC/UICC Stage II, T3-T4N0M0), a 2-Arm Multicenter Randomized Phase III Trial vs. Observation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]

Study Start Date: December 1999
Detailed Description:

OBJECTIVES:

  • Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery.
  • Determine overall survival and toxicity in the two treatment arms.

OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are stratified according to participating center, tumor thickness (greater than 1.5 to 3.0 mm vs greater than 3.0 to 4.0 mm vs greater than 4.0 mm), gender, ulceration (yes vs no), and presence of additional staging procedures of regional lymph nodes (yes vs no). Patients are randomized to one of two arms.

  • Arm I: Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks 1-4, 12, 24, 36, 48, 60, 72, 84, 96, 120, and 144 for a total of 14 vaccinations.
  • Arm II: Patients undergo observation. Patients are followed every 6 months for 7 years.

PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases

    • T3 or T4, N0, M0
    • Must originate in the skin
  • Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar

    • No more than 56 days since definitive surgical treatment (wide excision)
    • No more than 12 weeks since primary surgery
  • No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • 18 to 80

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.8 g/dL

Hepatic:

  • SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN
  • LDH no greater than 2 times ULN
  • Bilirubin no greater than 2 times ULN
  • Hepatitis B and C negative

Renal:

  • Creatinine normal

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer
  • No autoimmune disorders
  • No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids
  • No history of CNS demyelinating or inflammatory disease
  • No hereditary or acquired peripheral neuropathy
  • No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study
  • No history of severe allergic reaction to shellfish
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy
  • No other concurrent biologic therapy

Chemotherapy:

  • No prior systemic chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except replacement therapy
  • No concurrent corticosteroids
  • No concurrent chronic systemic steroids

Radiotherapy:

  • No prior adjuvant radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior preoperative infusion or perfusion therapy
  • No concurrent immunosuppressive medications
  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005052

  Show 80 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Alexander M. M. Eggermont, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
  More Information

Additional Information:
Publications:
Eggermont AM, Suciu S, Ruka W, et al.: EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results. [Abstract] J Clin Oncol 26 (Suppl 15): A-9004, 2008.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00005052     History of Changes
Other Study ID Numbers: CDR0000067645, EORTC-18961, BMS-CA152-003
Study First Received: April 6, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II 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
QS 21
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014