Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma

Original Study ID : CDR0000601698

Secondary ID : Array

NCT ID : NCT00726739

Brief Title : Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma

Official Title : A Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen (LMI) Vaccine for the Treatment of Stage IV Melanoma

Brief Summary :

RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma. PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with stage IV melanoma.

Source : National Cancer Institute (NCI)

Detailed Description :

OBJECTIVES: Primary - To compare the progression-free survival of patients with stage IV melanoma treated with aldesleukin with vs without allogeneic large multivalent immunogen melanoma vaccine LP2307. Secondary - To compare the clinical response in patients treated with these regimens. - To compare the 1- and 2-year survival rates in patients treated with these regimens. - To determine whether an immune response is generated after vaccination in these patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive allogeneic large multivalent immunogen melanoma vaccine LP2307 intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. - Arm II (control): Patients receive aldesleukin SC on days 1 and 2. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression may cross over and receive treatment on arm I. Patients undergo blood sample collection periodically for correlative laboratory studies. Samples are analyzed for immune responses to keyhole limpet hemocyanin and tetanus toxoid (control antigens) by ELISA assay; IFN-γ production by CD8 T cells in response to melanoma-derived peptides by ELISpot assay; delayed-type hypersensitivity response to vaccination; and frequency of peripheral blood lymphocytes, including T cells, B cells, NK cells, and monocytes, by flow cytometry. After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months until disease progression, and then periodically thereafter.

Overall Status : Recruiting

Start Date : June 2008

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Randomized, Active Control

Enrollment : 102

Verification Date : December 2008

First Received Date : July 31, 2008

Trial Eligibility

Criteria :
DISEASE CHARACTERISTICS:

- Diagnosis of melanoma

- Stage IV disease

- Measurable or nonmeasurable disease as defined by RECIST criteria

- Shares ≥ 1 class I HLA allele (A1, A2, B7, B8, C7) with the HLA-type SK23-CD80+ cell

- Concurrent enrollment in clinical trial UMN-MT1999-06 (IRB # 9904M01581, CPRC
#2002LS032): "Vaccination with Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to
Assess Antigen-Specific Immune Responses" required

- Patients who received tetanus toxoid within the past 7 years do not receive the
tetanus toxoid component of the vaccine

- Patients initially randomized to arm II on this study who cross over to arm I do
not receive a second KLH vaccination on UMN-MT1999-06

- No history of brain metastases or positive brain scan

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 80-100% OR ECOG PS 0-1

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 10 g/dL

- Bilirubin < 3 times upper limit of normal (ULN)

- AST < 3 times ULN

- Creatinine ≤ 2.0 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- FEV_1 ≥ 50% of predicted OR DLCO (corrected) ≥ 50% in patients meeting any of the
following criteria:

- History of symptomatic pulmonary disease

- Symptoms of dyspnea, rales, wheezes, or rhonchi on physical exam

- No cardiac disease, including any of the following:

- Myocardial infarction within the past 3 months

- Unstable angina

- Heart failure requiring medical intervention

- Exercise-induced ischemia

- Ejection fraction < 40% by MUGA or ECHO

- No autoimmune disease requiring immunosuppressive therapy

- No history of seafood allergy

- No hypersensitivity to any component of the vaccine, including thimerosal

- No history of neurologic symptoms from tetanus toxoid vaccine

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 4 weeks since prior systemic chemotherapy, immunotherapy, or biological
therapy and recovered

- No prior organ transplantation

- No concurrent immunosuppressive therapy or steroid therapy (e.g., prednisone)

- Concurrent topical or inhalational steroids allowed

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Masonic Cancer Center at University of Minnesota

Status : Recruiting

City : Minneapolis

State : Minnesota

Zip Code : 55455

Country : United States

OutComes

Primary OutComes

Measure : Progression-free survival

Safety issue : No

Secondary OutComes

Measure : Clinical response

Safety issue : No

Measure : Survival at 1 and 2 years

Safety issue : No

Measure : Immune response

Safety issue : No

Interventions

Type : Biological

Name : aldesleukin

Description : Given subcutaneously

Type : Biological

Name : allogeneic large multivalent immunogen melanoma vaccine LP2307

Description : Given intradermally

Clinical Trial Name - Aldesleukin With or Without Vaccine Therapy in Treating Patients With Stage IV Melanoma