Vaccine Therapy Plus Biological Therapy in Treating Adult... | NCT00019331 | Trialant
NCT00019331
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Jun 20, 2013Estimated
Enrollment
Not provided
Phase
Phase 2
Conditions
Colorectal Cancer
Endometrial Cancer
Head and Neck Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin)
Pancreatic Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
aldesleukin
ras peptide cancer vaccine
sargramostim
DetoxPC
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00019331
Obsolete or Duplicate NCT IDs
NCT00001581
Organization Study
CDR0000065656
Secondary IDs
ID
Type
Description
Link
NCI-97-C-0141F
NCI-T96-0078
Brief Title
Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
Official Title
Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Apr 2004
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 1997
Primary Completion Date
Not provided
Completion Date
May 2007Actual
First Submitted Date
Jul 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 19, 2013
Last Update Posted Date
Jun 20, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.
Detailed Description
OBJECTIVES:
Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients.
Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation.
Determine the type and characteristics of the cellular immune response generated.
Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF.
Correlate immune response with tumor response in patients treated with these regimens.
OUTLINE: Patients are assigned to one of three treatment groups.
Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks.
Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses.
Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II.
In all groups, patients receive up to 15 vaccinations in the absence of disease progression.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.
Conditions Module
Conditions
Colorectal Cancer
Endometrial Cancer
Head and Neck Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin)
Pancreatic Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
stage IV colon cancer
recurrent non-small cell lung cancer
stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
recurrent colon cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
advanced adult primary liver cancer
recurrent adult primary liver cancer
stage IV endometrial carcinoma
recurrent endometrial carcinoma
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IV papillary thyroid cancer
stage IV follicular thyroid cancer
thyroid gland medullary carcinoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
aldesleukin
Biological
ras peptide cancer vaccine
Biological
sargramostim
Biological
DetoxPC
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma
Ras mutations must be one of the following point mutations at codon 12:
Glycine to cysteine
Glycine to aspartic acid
Glycine to valine
Metastatic disease for which no known chemotherapy or radiotherapy would increase survival
Tumor tissue must be available for determination of ras mutation
No prior CNS metastases
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-1
Life expectancy:
More than 3 months
Hematopoietic:
WBC at least 2,000/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 2.0 mg/dL
SGOT/SGPT no greater than 4 times normal
No hepatitis B or C infection
Renal:
Creatinine no greater than 2.0 mg/dL
Cardiovascular:
No active ischemic heart disease (New York Heart Association class III or IV)
No myocardial infarction within the past 6 months
No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy
Immunologic:
No prior allergy to eggs
No prior autoimmune disease, including the following:
Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma
Myasthenia gravis
Goodpasture syndrome
Addison's disease, Hashimoto's thyroiditis, or active Graves' disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
No active infection requiring antibiotics
No medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
At least 4 weeks since prior steroids and recovered
Radiotherapy:
See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
Surgery:
Not specified
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Barry L. Gause, MD
National Cancer Institute (NCI)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
20892-1182
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
anaplastic thyroid cancer
recurrent thyroid cancer
stage IV melanoma
recurrent melanoma
stage IV non-small cell lung cancer
unspecified adult solid tumor, protocol specific
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
adult primary hepatocellular carcinoma
pulmonary carcinoid tumor
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
insular thyroid cancer
recurrent salivary gland cancer
stage IV salivary gland cancer
stage IV pancreatic cancer
Not provided
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
ID
Term
D015179
Colorectal Neoplasms
D016889
Endometrial Neoplasms
D006258
Head and Neck Neoplasms
D008113
Liver Neoplasms
D008175
Lung Neoplasms
D008545
Melanoma
D010190
Pancreatic Neoplasms
C563236
Testicular Germ Cell Tumor
D003110
Colonic Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
D055752
Small Cell Lung Carcinoma
D006528
Carcinoma, Hepatocellular
D013736
Testicular Neoplasms
D000077273
Thyroid Cancer, Papillary
D018263
Adenocarcinoma, Follicular
D018276
Carcinoma, Medullary
D065646
Thyroid Carcinoma, Anaplastic
D013964
Thyroid Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
Ancestor Terms
ID
Term
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
D014594
Uterine Neoplasms
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications