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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


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Alexander M. M. Eggermont, MD, PhD

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000067645

NCT ID:

NCT00005052

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage II melanoma
  • Melanoma

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