Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma - Full Text View

Purpose

Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells

Condition	Intervention	Phase
Recurrent Melanoma Stage IV Melanoma	Biological: aldesleukin Biological: gp100:209-217(210M) peptide vaccine Other: laboratory biomarker analysis	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical response rate (CR or PR) [ Time Frame: From the start of treatment until disease progression/recurrence, assessed up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
The Kaplan-Meier method will be used to estimate duration of response.
Progression-free intervals [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
The Kaplan-Meier method will be used to estimate time to progression.
Immunologic response rate using ELISPOT assay [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Described in terms of frequency and kinetics. Agreement between clinical and immunological response will be measured using the kappa coefficient.

Enrollment:	50
Study Start Date:	March 2001
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment (gp100:209-217, aldesleukin ) Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.	Biological: aldesleukin Given SC Other Names: IL-2 Proleukin recombinant human interleukin-2 recombinant interleukin-2 Biological: gp100:209-217(210M) peptide vaccine Given SC Other Names: G9 209-2M gp100:209-217(210M) Other: laboratory biomarker analysis Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.

II. Assess response duration and progression-free intervals in these patients receiving this treatment.

OUTLINE:

Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR.

Patients are followed every 9 weeks for 3 years or until disease recurrence.

PROJECTED ACCRUAL: A total of 25-50 patients will be accrued for this study within 3.5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease
HLA-A2*0201 positive by genotyping
Measurable disease as defined by the following:
- At least 1 lesion accurately measured in at least 1 dimension
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- Lesions considered intrinsically nonmeasurable include:
  - Bone lesions
  - Leptomeningeal disease
  - Ascites
  - Pleural/pericardial effusion
  - Inflammatory breast disease
  - Lymphangitis cutis/pulmonis
  - Abdominal masses not confirmed and followed by imaging techniques
  - Cystic lesions
  - Lesions situated in a previously irradiated area
No ocular or mucosal melanoma
No prior or concurrent liver or brain metastases
Performance status - ECOG 0-1
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL
LDH normal
Bilirubin normal
AST no greater than 2.5 times upper limit of normal
Creatinine normal
No congestive heart failure, angina, or symptomatic cardiac arrhythmia
No myocardial infarction within the past 6 months
No severe chronic pulmonary disease
Not pregnant or nursing
Fertile patients must use effective contraception
No primary or secondary immunodeficiency or autoimmune disease
No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer
At least 4 weeks since prior immunotherapy
No prior interleukin-2
No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine
No other concurrent cytokines or growth factors
At least 4 weeks since prior chemotherapy
At least 1 month since prior systemic corticosteroids
No concurrent systemic, inhaled, or topical corticosteroids
At least 1 month since other prior immunosuppressive medication
No antihypertensive medications from 1 day prior until 2 days after first course

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005949

Locations

United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John Roberts

Cancer and Leukemia Group B

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005949 History of Changes
Other Study ID Numbers:	NCI-2012-02337, CLB-509901, U10CA031946, CDR0000067886
Study First Received:	July 5, 2000
Last Updated:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013