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Pilot Trials With a KLH Conjugated Bivalent GangliosideVaccine Mixed With Immunological Adjuvants QS-DG or OPT-821in Patients With Disease Free AJCC Stage III or IV


N/A
21 Years
N/A
Not Enrolling
Both
Melanoma

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Trial Information

Pilot Trials With a KLH Conjugated Bivalent GangliosideVaccine Mixed With Immunological Adjuvants QS-DG or OPT-821in Patients With Disease Free AJCC Stage III or IV


Inclusion Criteria:



- Patients ≥18 with AJCC stage III or IV melanoma two weeks to one year after becoming
clinically free of disease will be eligible.

- For all patients' pathology slides must be reviewed by the Memorial Hospital
Department of Pathology to confirm diagnosis of cutaneous melanoma.

- All patients must have a Karnofsky performance status of ≥80.

- Patients may have received previous radiation, chemotherapy or systemic immunotherapy
(completed at least 4 weeks prior to vaccination).

- A CBC must be performed within 2 weeks prior to vaccination with the WBC > or equal
to 3.0 cells/mm3, Platelets >100,000/mm3,

- A screening profile must be performed within 2 weeks prior to vaccination with the
total bilirubin ≤ 2.0, and other LFTs within normal limits for patient's age.

- Chest, abdomen and pelvic CT or MRI must be performed within 4 weeks of the
initiation of treatment showing no evidence of disease.

- Women of child bearing potential and sexually active males must be counseled to use
an accepted and effective method of contraception (including abstinence) while on
treatment.

Exclusion Criteria:

- Patients previously treated with KLH or ganglioside containing vaccines, or
monoclonal antibodies against gangliosides are not eligible.

- Women must not be pregnant (negative βHCG within 2 weeks of vaccination if of
childbearing potential).

- Patients with other active cancers within the past 2 years, (excluding basal cell,
squamous carcinomas of the skin or cervical carcinoma-in-situ) are not eligible.

- Any medical condition which might make it difficult for the patient to complete the
full course of treatments or to respond immunologically to them is grounds for
exclusion, at the discretion of the Principal Investigator.

- Patients requiring anti-inflammatory medications such a steroids, NSAIDS or full dose
aspirin are not eligible.

- There must be no evidence of metastatic disease at the time of the first vaccine.
However, patients who develop new metastases during treatment may continue on
treatment as long as no systemic treatment is indicated and any local treatment such
as surgical resection or radiation would not cause a delay in vaccination or two
weeks or more.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the toxicity associated with a bivalent vaccine containing GD2 lactone (GD2L) and GD3 lactone (GD3L) covalently attached to the immunological carrier protein keyhole limpet hemocyanin (KLH), plus the immunological adjuvant QS-21 and OPT-821.

Outcome Time Frame:

conclusion of study

Safety Issue:

Yes

Principal Investigator

Paul Chapman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-086

NCT ID:

NCT00597272

Start Date:

December 2007

Completion Date:

November 2012

Related Keywords:

  • Melanoma
  • melanoma
  • resected local
  • systemic metastasis
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021