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Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin), Metastatic Cancer

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Trial Information

Laser and TLR-Agonist Immunotherapy: A Novel Autologous Melanoma Vaccine Study


OBJECTIVES:

Primary

- Determine the toxicity of in situ photoimmunotherapy comprising imiquimod and infrared
laser therapy with or without indocyanine green in patients with stage III or IV
melanoma and cutaneous metastases.

- Determine the complete systemic and local response rates in patients treated with this
regimen.

Secondary

- Determine the effect of this treatment on immunologic parameters in these patients.

OUTLINE: This is a prospective, open-label, pilot study.

Patients undergo in situ photoimmunotherapy (ISPI) comprising topical imiquimod twice daily
on days 1-42 and infrared laser therapy (with or without indocyanine green) on days 14 and
28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable
toxicity.

Blood is collected at baseline, prior to ISPI, 24 hours after ISPI, and at week 6. Samples
are examined for cytokine response, CD8 T-cell activation and regulatory T-cell assays (by
flow cytometry), and antibody response (by western blot).

After completion of study treatment, patients are followed monthly for 3 months and then
every 3 months for up to 2 years.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed melanoma meeting the following criteria:

- Stage III or IV disease

- Stage IV disease without observable, surgically unresectable metastases
beyond the immediate treatment site allowed

- Presence of 1 or more cutaneous metastases ≤ 3 cm in size

- Diffuse areas of tumor involvement can be used to qualify for the study if
these areas involve primarily the epidermis and/or dermis and are less than
3 cm in thickness

- No uncontrolled brain metastases

- Treated brain metastases that are stable for 3 months allowed at the
investigator's discretion

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 4 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study
completion

- No known allergy to any drugs used during study treatment

- No unstable medical illness

- Not immunosuppressed

- Patients immunosuppressed due to disease (e.g., HIV positive) allowed

PRIOR CONCURRENT THERAPY:

- No systemic steroids or any other immunosuppressive medications within the past month

- No chemotherapy within the past 4 weeks

- No radiotherapy to the treatment site within the past 4 weeks

- Palliative radiotherapy to sites other than cutaneous treatment and assessment
sites allowed

- No concurrent immunosuppressive agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity and tolerability by CTCAE version 3.0

Safety Issue:

Yes

Principal Investigator

Mark Naylor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma Health Sciences Center - Tulsa

Authority:

United States: Federal Government

Study ID:

CDR0000536471

NCT ID:

NCT00453050

Start Date:

March 2006

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Metastatic Cancer
  • stage III melanoma
  • stage IV melanoma
  • skin metastases
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104