Vaccine Therapy in Treating Patients With Primary Stage II Melanoma

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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

Disease-free survival

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

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 *

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.
Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

* 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

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

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