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Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

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.
 
ClinicalTrials.gov Identifier: NCT00005052
Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 6, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 9, 2009
Study Start Date  ICMJE December 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
Disease-free survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2007)
  • Duration of survival
  • Toxicity as assessed by CTC v2
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Biological: GM2-KLH vaccine
  • Biological: QS21
  • Procedure: adjuvant therapy
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   Estonia,   Finland,   France,   Germany,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Serbia,   Spain,   Switzerland,   United Kingdom
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00005052
Other Study ID Numbers  ICMJE CDR0000067645
EORTC-18961
BMS-CA152-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Alexander M. M. Eggermont, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
PRS Account National Cancer Institute (NCI)
Verification Date January 2006

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