Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

• Sponsor: Agenus Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01147536
• Collaborator: (none)
• Enrollment: 12
• Locations: 3
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Biological: HSPPC-96	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage) for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HSPPC-96 Vaccine 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.	Biological: HSPPC-96; Other Names: HSPPC-96 (Heat Shock Protein-Peptide Complex) Prophage Autologous Tumor-Derived HSPPC-96

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay [6-7 weeks post surgery up to Week 14]

   The ELISPOT assay was not developed for this study and no immunogenicity data are available.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of

= 25% clear cell carcinoma

• American joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence

• At least 8 doses of vaccine available from participant's tumor

• Life expectancy of at least 3 months

• Eastern cooperative oncology group performance status of 0 or 1

• Cardiovascular disease status of new york heart association class less than 2

• Adequate hematopoietic, renal and hepatic function

• Negative serology tests for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (anti-HCV-Ab)

• Females must have negative pregnancy test

Exclusion Criteria:

• Evidence of metastatic or residual RCC

• Documented radiological enlarged lymph nodes

• Females who are pregnant or breastfeeding

• Use of any other investigational product from 4 weeks post-surgery

• Splenectomy performed during nephrectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Care Physicians	Albany	New York	United States	12208
2	MD Anderson Cancer Center	Houston	Texas	United States	77030
3	Pavillion de Recherche de Hotel Dieu	Quebec		Canada	G1R 2J6

Sponsors and Collaborators

• Agenus Inc.

Investigators

• Principal Investigator: Louis Lacombe, MD, FRCSC, Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec
• Principal Investigator: Christopher G Wood, MD, FACS, The University of Texas MD Anderson Cancer Center
• Principal Investigator: Ronald P Kaufman, MD, FACS, Community Care Physicians, PC; The Urological Institute of Northeastern New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Agenus Inc.
• ClinicalTrials.gov Identifier: NCT01147536
• Other Study ID Numbers: C-100-38; NCT01073254
• First Posted: Jun 22, 2010
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Renal Cell; Recurrence

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	HSPPC-96 Vaccine
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
Received at Least 1 Dose of Study Drug	12
COMPLETED	9
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	HSPPC-96 Vaccine
Arm/Group Description	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.
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.5 (11.48)
Sex: Female, Male (Count of Participants)
Female	2 16.7%
Male	10 83.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
Description	The ELISPOT assay was not developed for this study and no immunogenicity data are available.
Time Frame	6-7 weeks post surgery up to Week 14

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	HSPPC-96 Vaccine
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	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
Adverse Event Reporting Description	Safety population included all participants who received at least 1 dose of study drug.
Arm/Group Title	HSPPC-96 Vaccine
Arm/Group Description	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.
All Cause Mortality
	HSPPC-96 Vaccine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	HSPPC-96 Vaccine
	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)
Infections and infestations
Clostridium colitis	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Myopathy	1/12 (8.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma	1/12 (8.3%)
Psychiatric disorders
Completed suicide	1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	HSPPC-96 Vaccine
	Affected / at Risk (%)	# Events
Total	11/12 (91.7%)
Blood and lymphatic system disorders
Anaemia	1/12 (8.3%)
Leukocytosis	1/12 (8.3%)
Thrombocythaemia	1/12 (8.3%)
Thrombocytopenia	1/12 (8.3%)
Cardiac disorders
Tachycardia	1/12 (8.3%)
Ear and labyrinth disorders
Ear congestion	1/12 (8.3%)
Endocrine disorders
Hypercorticoidism	1/12 (8.3%)
Eye disorders
Eye discharge	1/12 (8.3%)
Keratoconjuctivitis sicca	1/12 (8.3%)
Gastrointestinal disorders
Abdominal pain lower	1/12 (8.3%)
Constipation	1/12 (8.3%)
Diarrhoea	2/12 (16.7%)
Haemorrhoids	1/12 (8.3%)
Loose stools	1/12 (8.3%)
Nausea	1/12 (8.3%)
Proctalgia	1/12 (8.3%)
Vomiting	1/12 (8.3%)
General disorders
Difficulty in walking	1/12 (8.3%)
Fatigue	3/12 (25%)
Injection site reaction	1/12 (8.3%)
Pain	1/12 (8.3%)
Pyrexia	1/12 (8.3%)
Hepatobiliary disorders
Cholelithiasis	1/12 (8.3%)
Infections and infestations
Influenza	1/12 (8.3%)
Nasopharyngitis	1/12 (8.3%)
Urinary tract infection	1/12 (8.3%)
Injury, poisoning and procedural complications
Pancreatic anastomotic leak	1/12 (8.3%)
Wound	1/12 (8.3%)
Investigations
Blood creatinine increased	1/12 (8.3%)
Blood glucose increased	1/12 (8.3%)
Blood pressure increased	2/12 (16.7%)
Blood urea increased	1/12 (8.3%)
Glomerular filtration rate decreased	1/12 (8.3%)
Metabolism and nutrition disorders
Hyperglycaemia	1/12 (8.3%)
Hyperkalaemia	1/12 (8.3%)
Hypoalbuminaemia	1/12 (8.3%)
Hypocalcaemia	1/12 (8.3%)
Hypokalaemia	1/12 (8.3%)
Malnutrition	1/12 (8.3%)
Metabolic acidosis	1/12 (8.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/12 (8.3%)
Musculoskeletal pain	1/12 (8.3%)
Neck pain	1/12 (8.3%)
Athralgia	2/12 (16.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm	1/12 (8.3%)
Lung nodule	2/12 (16.7%)
Nervous system disorders
Dizziness	2/12 (16.7%)
Headache	1/12 (8.3%)
Psychiatric disorders
Anxiety	1/12 (8.3%)
Insomnia	1/12 (8.3%)
Renal and urinary disorders
Dysuria	1/12 (8.3%)
Renal failure acute	1/12 (8.3%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/12 (8.3%)
Dyspnoea	1/12 (8.3%)
Hydropneumothorax	1/12 (8.3%)
Nasal congestion	2/12 (16.7%)
Pleural effusion	1/12 (8.3%)
Pneumothorax	1/12 (8.3%)
Skin and subcutaneous tissue disorders
Actinic keratosis	1/12 (8.3%)
Skin ulcer	1/12 (8.3%)
Vascular disorders
Haemodynamic instability	1/12 (8.3%)
Hypotension	1/12 (8.3%)

Limitations/Caveats

Due to Business reasons, the study was terminated early and the Part 2 portion was not conducted.

More Information

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.