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Clinical Trial Name - Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma

 
Original Study ID : CDR0000067886
Secondary ID : CLB-509901
NCT ID : NCT00005949
Brief Title : Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
Official Title : Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
Brief Summary :

RATIONALE: 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. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma.

Source : National Cancer Institute (NCI)
Detailed Description :

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

Overall Status : Completed
Start Date : December 2000
Official Title : Phase 2
Phase : Interventional
Study Design : Treatment
Verification Date : May 2003
First Received Date : July 5, 2000
Trial Eligibility
Criteria :
DISEASE CHARACTERISTICS:

- 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 OR

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- LDH normal

- Bilirubin normal

- AST no greater than 2.5 times upper limit of normal

Renal:

- Creatinine normal

Cardiovascular:

- No congestive heart failure, angina, or symptomatic cardiac arrhythmia

- No myocardial infarction within the past 6 months

Pulmonary:

- No severe chronic pulmonary disease

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- 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

Chemotherapy:

- At least 4 weeks since prior chemotherapy

Endocrine therapy:

- At least 1 month since prior systemic corticosteroids

- No concurrent systemic, inhaled, or topical corticosteroids

Radiotherapy:

- See Disease Characteristics

Surgery:

- Not specified

Other:

- At least 1 month since other prior immunosuppressive medication

- No antihypertensive medications from 1 day prior until 2 days after first course
Gender : Both
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Veterans Affairs Medical Center - Birmingham
City : Birmingham
State : Alabama
Zip Code : 35233-1996
Country : United States
Facility Name : Rebecca and John Moores UCSD Cancer Center
City : La Jolla
State : California
Zip Code : 92093-0658
Country : United States
Facility Name : UCSF Comprehensive Cancer Center
City : San Francisco
State : California
Zip Code : 94143-0128
Country : United States
Facility Name : Veterans Affairs Medical Center - San Francisco
City : San Francisco
State : California
Zip Code : 94121
Country : United States
Facility Name : CCOP - Christiana Care Health Services
City : Wilmington
State : Delaware
Zip Code : 19899
Country : United States
Facility Name : Lombardi Cancer Center
City : Washington
State : District of Columbia
Zip Code : 20007
Country : United States
Facility Name : Walter Reed Army Medical Center
City : Washington
State : District of Columbia
Zip Code : 20307-5000
Country : United States
Facility Name : CCOP - Mount Sinai Medical Center
City : Miami Beach
State : Florida
Zip Code : 33140
Country : United States
Facility Name : University of Chicago Cancer Research Center
City : Chicago
State : Illinois
Zip Code : 60637-1470
Country : United States
Facility Name : Veterans Affairs Medical Center - Chicago (Westside Hospital)
City : Chicago
State : Illinois
Zip Code : 60612
Country : United States
Facility Name : Holden Comprehensive Cancer Center
City : Iowa City
State : Iowa
Zip Code : 52242-1009
Country : United States
Facility Name : Veterans Affairs Medical Center - Togus
City : Togus
State : Maine
Zip Code : 04330
Country : United States
Facility Name : Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City : Baltimore
State : Maryland
Zip Code : 21201
Country : United States
Facility Name : Dana-Farber Cancer Institute
City : Boston
State : Massachusetts
Zip Code : 02115
Country : United States
Facility Name : University of Massachusetts Memorial Medical Center - University Campus
City : Worcester
State : Massachusetts
Zip Code : 01655
Country : United States
Facility Name : University of Minnesota Cancer Center
City : Minneapolis
State : Minnesota
Zip Code : 55455
Country : United States
Facility Name : Veterans Affairs Medical Center - Minneapolis
City : Minneapolis
State : Minnesota
Zip Code : 55417
Country : United States
Facility Name : Barnes-Jewish Hospital
City : Saint Louis
State : Missouri
Zip Code : 63110
Country : United States
Facility Name : Ellis Fischel Cancer Center - Columbia
City : Columbia
State : Missouri
Zip Code : 65203
Country : United States
Facility Name : Veterans Affairs Medical Center - Columbia (Truman Memorial)
City : Columbia
State : Missouri
Zip Code : 65201
Country : United States
Facility Name : University of Nebraska Medical Center
City : Omaha
State : Nebraska
Zip Code : 68198-7680
Country : United States
Facility Name : CCOP - Southern Nevada Cancer Research Foundation
City : Las Vegas
State : Nevada
Zip Code : 89106
Country : United States
Facility Name : Norris Cotton Cancer Center
City : Lebanon
State : New Hampshire
Zip Code : 03756-0002
Country : United States
Facility Name : CCOP - North Shore University Hospital
City : Manhasset
State : New York
Zip Code : 11030
Country : United States
Facility Name : CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City : Syracuse
State : New York
Zip Code : 13217
Country : United States
Facility Name : Memorial Sloan-Kettering Cancer Center
City : New York
State : New York
Zip Code : 10021
Country : United States
Facility Name : Mount Sinai Medical Center, NY
City : New York
State : New York
Zip Code : 10029
Country : United States
Facility Name : New York Presbyterian Hospital - Cornell Campus
City : New York
State : New York
Zip Code : 10021
Country : United States
Facility Name : North Shore University Hospital
City : Manhasset
State : New York
Zip Code : 11030
Country : United States
Facility Name : Roswell Park Cancer Institute
City : Buffalo
State : New York
Zip Code : 14263-0001
Country : United States
Facility Name : State University of New York - Upstate Medical University
City : Syracuse
State : New York
Zip Code : 13210
Country : United States
Facility Name : Veterans Affairs Medical Center - Buffalo
City : Buffalo
State : New York
Zip Code : 14215
Country : United States
Facility Name : Veterans Affairs Medical Center - Syracuse
City : Syracuse
State : New York
Zip Code : 13210
Country : United States
Facility Name : CCOP - Southeast Cancer Control Consortium
City : Winston-Salem
State : North Carolina
Zip Code : 27104-4241
Country : United States
Facility Name : Comprehensive Cancer Center at Wake Forest University
City : Winston-Salem
State : North Carolina
Zip Code : 27157-1082
Country : United States
Facility Name : Duke Comprehensive Cancer Center
City : Durham
State : North Carolina
Zip Code : 27710
Country : United States
Facility Name : Lineberger Comprehensive Cancer Center, UNC
City : Chapel Hill
State : North Carolina
Zip Code : 27599-7295
Country : United States
Facility Name : Veterans Affairs Medical Center - Durham
City : Durham
State : North Carolina
Zip Code : 27705
Country : United States
Facility Name : Arthur G. James Cancer Hospital - Ohio State University
City : Columbus
State : Ohio
Zip Code : 43210-1240
Country : United States
Facility Name : Rhode Island Hospital
City : Providence
State : Rhode Island
Zip Code : 02903
Country : United States
Facility Name : University of Tennessee Cancer Institute
City : Memphis
State : Tennessee
Zip Code : 38103
Country : United States
Facility Name : Veterans Affairs Medical Center - Memphis
City : Memphis
State : Tennessee
Zip Code : 38104
Country : United States
Facility Name : Green Mountain Oncology Group
City : Bennington
State : Vermont
Zip Code : 05201
Country : United States
Facility Name : Vermont Cancer Center
City : Burlington
State : Vermont
Zip Code : 05401-3498
Country : United States
Facility Name : Veterans Affairs Medical Center - White River Junction
City : White River Junction
State : Vermont
Zip Code : 05009
Country : United States
Facility Name : Massey Cancer Center
City : Richmond
State : Virginia
Zip Code : 23219
Country : United States
Facility Name : Veterans Affairs Medical Center - Richmond
City : Richmond
State : Virginia
Zip Code : 23249
Country : United States
Interventions
Type : Biological
Name : aldesleukin
Type : Biological
Name : gp100 antigen
Type : Biological
Name : incomplete Freund's adjuvant
 
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