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Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT00019682
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Recurrent Melanoma
Stage IIIA Skin Melanoma
Stage IIIB Skin Melanoma
Stage IIIC Skin Melanoma
Stage IV Skin Melanoma
Interventions Biological: Aldesleukin
Biological: gp100 Antigen
Drug: Montanide ISA 51 VG
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
Enrollment 185
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 94 91
Completed 93 85
Not Completed 1 6
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin) Total
Hide Arm/Group Description

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 94 91 185
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 94 participants 91 participants 185 participants
50.3
(18 to 65)
46.9
(18 to 65)
48.6
(18 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 91 participants 185 participants
Female
31
  33.0%
34
  37.4%
65
  35.1%
Male
63
  67.0%
57
  62.6%
120
  64.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 91 participants 185 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
93
  98.9%
91
 100.0%
184
  99.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.1%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Best Response Rate (Partial Response [PR] + Complete Response [CR])
Hide Description A complete response (CR) was defined as the disappearance of all clinical evidence of disease for at least 4 weeks. A partial response (PR) was defined as a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions could appear, and none could increase 25% or more.
Time Frame Up to 12 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description:

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 93 85
Measure Type: Count of Participants
Unit of Measure: Participants
6
   6.5%
14
  16.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival was compared between groups by means of Kaplan-Meier curves using the log-rank test to evaluate the significance of the difference between the arms.
Time Frame From the date of randomization until documentation of progression or last follow up, assessed up to 12 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description:

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 94 91
Median (95% Confidence Interval)
Unit of Measure: months
1.6
(1.5 to 1.8)
2.2
(1.7 to 3.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Unadjusted 2 tail p value.
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Change in T-cell Precursors
Hide Description To measure change in T-cell precursors, PBMC were tested for reactivity by measuring gamma-interferon release after overnight coculture with peptide pulsed T2 cells. PBMC obtained after 4 cycles of study treatment were compared to pre treatment PBMC. A positive assay was defined as greater than 100pg/ml gamma-interferon release and at least twice the release (including all control peptides) by post treatment PBMC compared to pre treatment PBMC.
Time Frame Baseline to up to 12 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with paired cryopreserved peripheral blood lymphocytes obtained before any treatment and after completing 4 cycles of treatment.
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description:

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 12 37
Measure Type: Number
Unit of Measure: Participants with a positive assay
0 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change in Quality of Life (QOL) Score Assessed by the FACT-G (Functional Assessment of Cancer Therapy- General), FACT-F (Functional Assessment of Cancer Therapy- Fatigue), SF-36 (Short Form 36) and SDS (Symptom Distress Scale)
Hide Description QOL was measured before and after 2 cycles of treatment using 4 measures: FACT-G is a 27 item measure of QOL. A total score is calculated by summing across responses on a 5 point scale and ranges from 0-135, with higher scores indicating better QOL. FACT-F is 13 item measure of fatigue. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 0-52, with higher scores indicating less fatigue. SF-36 is a 36 item measure of self-reported health status. SF-36 is comprised of 8 subscales: physical function, role physical, bodily pain vitality, role emotional function, mental health, social function and general health. Summated scores range from 0-100, with higher scores indicating a better health state. SDS is a 13 item measure of symptom distress. A total score is calculated by summing across responses on a 5 point scale. Total score ranges from 13 to 65, with higher scores indicating more symptom distress.
Time Frame Baseline to up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description:

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 93 85
Mean (Standard Error)
Unit of Measure: units on a scale
Pre treatment FACT-G 84.2  (2.77) 83.8  (2.74)
Post treatment FACT-G 76.4  (2.75) 81.2  (2.71)
Pre treatment FACT-F 43.1  (1.47) 41.5  (1.42)
Post treatment FACT-F 36.1  (1.78) 36.3  (1.73)
Pre treatment SF-36 49.1  (1.93) 46.6  (1.85)
Post treatment SF-36 42.6  (1.94) 42.9  (1.89)
Pre treatment SDS 21.3  (1.05) 21.2  (1.05)
Post treatment SDS 24.6  (1.17) 22.8  (1.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments FACT-G scale
Type of Statistical Test Non-Inferiority
Comments Evaluated inferiority in quality of life outcomes between arms.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments FACT-F scale
Type of Statistical Test Non-Inferiority
Comments Evaluated inferiority in quality of life outcomes between arms.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments SF-36 scale
Type of Statistical Test Non-Inferiority
Comments Evaluated inferiority in quality of life outcomes between arms.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (Aldesleukin), Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Comments SDS scale
Type of Statistical Test Non-Inferiority
Comments Evaluated inferiority in quality of life outcomes between arms.
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description NCI Common Toxicity Criteria Version 2.0 were used for adverse event monitoring. For reporting purposes the individual toxicities were grouped under their respective headings.
 
Arm/Group Title Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Hide Arm/Group Description

Patients receive aldesleukin IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Patients receive gp100 antigen emulsified in Montanide ISA-51 SC on day 1. Patients also receive aldesleukin as in Arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Aldesleukin: Given IV

gp100 Antigen: Given SC

Montanide ISA 51 VG: Given SC

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/93 (1.08%)   2/85 (2.35%) 
General disorders     
Death   1/93 (1.08%)  2/85 (2.35%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Aldesleukin) Arm II (gp100 Antigen in Montanide IDA-51 and Aldesleukin)
Affected / at Risk (%) Affected / at Risk (%)
Total   93/93 (100.00%)   85/85 (100.00%) 
Blood and lymphatic system disorders     
Blood or bone marrow   33/93 (35.48%)  41/85 (48.24%) 
Cardiac disorders     
Arrhythmia   4/93 (4.30%)  16/85 (18.82%) 
General   25/93 (26.88%)  31/85 (36.47%) 
Gastrointestinal disorders     
Gastrointestinal   17/93 (18.28%)  18/85 (21.18%) 
General disorders     
Constitutional symptoms   15/93 (16.13%)  24/85 (28.24%) 
Pain   10/93 (10.75%)  11/85 (12.94%) 
Hepatobiliary disorders     
Hepatic   36/93 (38.71%)  34/85 (40.00%) 
Infections and infestations     
Infection or febrile neutropenia   6/93 (6.45%)  7/85 (8.24%) 
Metabolism and nutrition disorders     
Metabolic or laboratory-testing result   19/93 (20.43%)  36/85 (42.35%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal   3/93 (3.23%)  6/85 (7.06%) 
Nervous system disorders     
Neurologic   11/93 (11.83%)  22/85 (25.88%) 
Renal and urinary disorders     
Renal or genitourinary   14/93 (15.05%)  16/85 (18.82%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary   19/93 (20.43%)  19/85 (22.35%) 
Skin and subcutaneous tissue disorders     
Skin   6/93 (6.45%)  6/85 (7.06%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Douglas Schwartzentruber
Organization: Indiana University Health
Phone: 317-948-6873
EMail: dschwart@iuhealth.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019682     History of Changes
Obsolete Identifiers: NCT00001801
Other Study ID Numbers: NCI-2012-02897
NCI-2012-02897 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000066963
99-C-0051 ( Other Identifier: IU Health Goshen Center for Cancer Care )
T98-0085 ( Other Identifier: CTEP )
First Submitted: July 11, 2001
First Posted: January 27, 2003
Results First Submitted: December 2, 2016
Results First Posted: November 20, 2017
Last Update Posted: November 20, 2017