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Sponsor's business decision
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The primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.
The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation) and Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study). The study was terminated early with 12 participants enrolled only in Part 1a and Part 1b. Part 2 of the study involved randomization after 8 doses of HSSPC-96. After the 8 doses of HSSPC-96 administered in Part 2, the participants were to be randomized to the treatment extension arm or the placebo extension arm. There were no participants enrolled in Part 2 since the study was terminated early. Therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSPPC-96 Vaccine | Experimental | Participants will receive up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants will remain untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.](streamdown:incomplete-link) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSPPC-96 | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay | The ELISPOT assay was not developed for this study and no immunogenicity data are available. | 6-7 weeks post surgery up to Week 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Lacombe, MD, FRCSC | Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec | Principal Investigator |
| Christopher G Wood, MD, FACS | M.D. Anderson Cancer Center | Principal Investigator |
| Ronald P Kaufman, MD, FACS | Community Care Physicians, PC; The Urological Institute of Northeastern New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Care Physicians | Albany | New York | 12208 | United States | ||
| MD Anderson Cancer Center |
The study consisted of Part 1 (Part 1a [assessment of immune variation] and Part 2a [assay standardization]) and Part 2 (immune monitoring). Due to Business reasons, the study did not advanced to the Part 2 portion. The results presented below are for Part 1 only. Per planned analysis, data were analyzed and collected combined for Part 1a and 1b.
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| ID | Title | Description |
|---|---|---|
| FG000 | HSPPC-96 Vaccine | Participants received up to 8 administrations of HSPPC-96 (heat shock protein peptide complex-96) (Vitespen or Oncophage) 25 micrograms [µg] intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.](streamdown:incomplete-link) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Houston |
| Texas |
| 77030 |
| United States |
| Pavillion de Recherche de Hotel Dieu | Québec | G1R 2J6 | Canada |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | HSPPC-96 Vaccine | Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.](streamdown:incomplete-link) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay | The ELISPOT assay was not developed for this study and no immunogenicity data are available. | No Participants Provided Immunology Data. No Participants Provided Immunology Data. The ELISPOT assay was not developed for this study, and no immunogenicity data were collected for analysis. | Posted | 6-7 weeks post surgery up to Week 14 |
|
|
From the date of first immune monitoring blood draw (6-7 weeks post surgery) through the end of study evaluation (12 months) or 30 days post last dose (Week 29 for Part 1a and Week 19 for Part 1b), whichever was earlier
Safety population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HSPPC-96 Vaccine | Participants received up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants remained untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.](streamdown:incomplete-link) | 2 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium colitis | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypercorticoidism | Endocrine disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Keratoconjuctivitis sicca | Eye disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Loose stools | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Difficulty in walking | General disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 7.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 7.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 7.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 7.0 | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | MedDRA 7.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Benign lymph node neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
| |
| Lung nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Haemodynamic instability | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Athralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
Due to Business reasons, the study was terminated early and the Part 2 portion was not conducted.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Agenus, Inc. Clinical Trial Information | Agenus Inc. | 781-674-4265 | clinicaltrialinfo@Agenusbio.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C484813 | vitespin |
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